Tissue Collection and Natural History Study of Patients with Myelodysplastic Syndrome or Myeloproliferative Neoplasms

Status: Active

Description

This research trial collects tissue samples from and studies the history of patients with myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN). Collecting and storing patients' bone marrow, blood, eyebrow hairs, buccal swab, skin, or other tissues to be studied in the laboratory in the future may help doctors learn more about MDS and blood disorders that may lead to MDS. Collecting information about patients and the treatments they receive may allow doctors to better understand how MDS changes over time and this knowledge may lead to better ways to prevent, detect, and treat MDS in the future.

Eligibility Criteria

Inclusion Criteria

  • Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone marrow assessments OR
  • Diagnosed with de novo or therapy-related MDS within 6-months of enrollment per the World Health Organization (WHO) criteria and undergoing clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate disease status
  • Bone marrow aspirate expected to be performed within 1 week of registration, and in all cases must be performed no later than 4 weeks after enrollment
  • No prior treatment for MDS at entry and through the time of the entry bone marrow aspirate
  • No treatment with hematopoietic growth factors in prior 6 months
  • If anemic without prior MDS diagnosis, the following tests within the prior 6 months; values that are significantly outside of normal range do not exclude participation but should prompt investigation of alternative etiologies for anemia * B12 level * Serum folate * Mean corpuscular volume (MCV) * Red cell distribution width (RDW) * Ferritin * Iron studies (iron, total iron-binding capacity [TIBC] test, percent saturation)
  • No diagnosis of a solid tumor or hematologic malignancy within two years prior to enrollment except for in situ cancer of the skin (basal or squamous cell), cervix, bladder, breast, or prostate
  • No treatment with radiation therapy in the two years prior to registration
  • No non-hormonal treatment for malignancy within the two years prior to registration
  • No established hereditary bone marrow failure syndrome
  • No known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte leukemia
  • Not enrolled in the Connect MDS/Acute Myeloid Leukemia (AML) Disease Registry
  • In participants with suspected MDS and prior to registration with subsequent bone marrow evaluation, alternative causes for the cytopenias should be considered (e.g., internal bleeding, autoimmune cytopenias, thyroid disorders, other causes of anemia etc.); in select individuals, the following tests could be performed to assist in the diagnostic work-up; these evaluations are not required by the protocol; however, abnormal results in advance of enrollment may reduce the number of non-MDS cases * Copper, serum level * Direct antiglobulin test * Antinuclear antibody (ANA) test * Creatinine * Calculated glomerular filtration rate (GFR) * Thyroid-stimulating hormone (TSH) tests performed in prior 6 months ** Based on centralized pathology review, participants will be classified into the longitudinal cohort of cases (MDS, MDS/MPN overlap disorders, AML with < 30% blasts without core binding factor or acute promyelocytic leukemia [AML < 30% blasts including chromosomal rearrangements between chromosomes 8 and 21 and within chromosome 16 as well as t(15;17)], or idiopathic cytopenia of undetermined significance [ICUS]) and the cross-sectional cohort (all others); it is not known in advance what percentages of individuals will fall into each cohort; in addition to baseline biological samples, longitudinal samples and data will be collected for approximately 2000 cases of MDS or MDS/MPN overlap disorders and 500 cases of ICUS assigned to the longitudinal cohort; sample and data collection will cease at baseline for all cases assigned to the cross-sectional cohort; submitted samples will be reviewed by a central pathologist to determine eligibility for the longitudinal cohort (i.e., an MDS, MDS/MPN, AML with < 30% blasts without core binding factor or acute promyelocytic leukemia, or ICUS diagnosis); should a discrepancy in diagnosis occur between the central review and study site, the study site will be notified to allow for additional information to be submitted to clarify the diagnosis; such notifications will not occur in real time, and are not intended to assist in patient care

Locations & Contacts

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Irvine
Kaiser Permanente-Irvine
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-Cadillac
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Panorama City
Kaiser Permanente - Panorama City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Riverside
Kaiser Permanente-Riverside
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Diego
Kaiser Permanente-San Diego Zion
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Marcos
Kaiser Permanente-San Marcos
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org

Connecticut

New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
West Haven
Veterans Affairs Connecticut Healthcare System-West Haven Campus
Status: Active
Contact: Site Public Contact
Phone: 203-937-3421ext2832

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Regional Hematology and Oncology PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Jacksonville
Baptist MD Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 904-202-7051
Mayo Clinic in Florida
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Tampa
Moffitt Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-456-7121
Email: canceranswers@moffitt.org
Vero Beach
Indian River Medical Center
Status: Active
Contact: Site Public Contact
Phone: 772-563-4673

Georgia

Gainesville
Northeast Georgia Medical Center-Gainesville
Status: Active
Contact: Site Public Contact
Phone: 770-219-8800
Email: cancerpatient.navigator@nghs.com
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Hawaii

Aiea
Hawaii Oncology Inc-Pali Momi
Status: Active
Contact: Site Public Contact
Phone: 808-487-7447
Honolulu
Hawaii Cancer Care Inc-Liliha
Status: Active
Contact: Site Public Contact
Phone: 808-536-4888
Hawaii Cancer Care Inc-POB II
Status: Active
Contact: Site Public Contact
Phone: 808-524-6115
Hawaii Oncology Inc-Kuakini
Status: Active
Contact: Site Public Contact
Phone: 808-531-8521
Hawaii Oncology Inc-POB I
Status: Active
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
University of Hawaii Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 808-586-2979

Idaho

Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: Active
Contact: Site Public Contact
Phone: 618-457-5200
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 618-985-3333
Email: clinical.research@sih.net
Centralia
Centralia Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Elk Grove Village
AMITA Health Alexian Brothers Medical Center
Status: Active
Contact: Site Public Contact
Phone: 847-952-7164
Email: fredianc@alexian.net
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Hinsdale
AMITA Health Cancer Institute and Outpatient Center
Status: Active
Contact: Site Public Contact
Phone: 630-286-5500
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Iowa

Cedar Rapids
Oncology Associates at Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 319-363-2690
Des Moines
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Site Public Contact
Phone: 515-282-2921

Kansas

Chanute
Cancer Center of Kansas - Chanute
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Dodge City
Cancer Center of Kansas - Dodge City
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Fort Scott
Cancer Center of Kansas - Fort Scott
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Independence
Cancer Center of Kansas-Independence
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Kingman
Cancer Center of Kansas-Kingman
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Liberal
Cancer Center of Kansas-Liberal
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Newton
Cancer Center of Kansas - Newton
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Parsons
Cancer Center of Kansas - Parsons
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Pratt
Cancer Center of Kansas - Pratt
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Salina
Cancer Center of Kansas - Salina
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wellington
Cancer Center of Kansas - Wellington
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wichita
Associates In Womens Health
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas - Wichita
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Via Christi Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org
Winfield
Cancer Center of Kansas - Winfield
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Maine

York
York Hospital
Status: Active
Contact: Site Public Contact
Phone: 207-351-3777

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Bel Air
Upper Chesapeake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-643-3010

Massachusetts

Worcester
University of Massachusetts Medical School
Status: Active
Contact: Site Public Contact
Phone: 508-856-3216
Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Site Public Contact
Phone: 517-975-9547
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Reed City
Spectrum Health Reed City Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Royal Oak
William Beaumont Hospital-Royal Oak
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Southfield
Ascension Providence Hospitals - Southfield
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Troy
William Beaumont Hospital - Troy
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Wyoming
Metro Health Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Duluth
Essentia Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Essentia Health Saint Mary's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-203-7267
Miller-Dwan Hospital
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Saint Luke's Hospital of Duluth
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis Veterans Medical Center
Status: Active
Contact: Site Public Contact
Phone: 612-467-2800
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Jefferson City
Capital Region Southwest Campus
Status: Active
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Joseph
Heartland Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 816-271-7937
Email: linda.schumacher@mymlc.com
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Nevada

Henderson
Nevada Cancer Specialists-Saint Rose
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas
Nevada Cancer Specialists?Oakey
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Nevada Cancer Specialists-Fort Apache
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Nevada Cancer Specialists-Tenaya
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Jersey

Woodbury
Inspira Medical Center Woodbury
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Brooklyn
Maimonides Medical Center
Status: Active
Contact: Site Public Contact
Phone: 718-765-2500
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 607-271-7000
Glens Falls
Glens Falls Hospital
Status: Active
Contact: Site Public Contact
Phone: 518-926-6700
Lake Success
Northwell Health / Center for Advanced Medicine
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
Manhasset
North Shore University Hospital
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New Hyde Park
Long Island Jewish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Site Public Contact
Phone: 828-213-4150
Email: leslie.verner@msj.org
Durham
Durham Veterans Affairs Medical Center
Status: Active
Contact: Site Public Contact
Phone: 919-286-0411
Email: Nicole.Roberge@VA.gov

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: tamara.fischer@sanfordhealth.org
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
MetroHealth Medical Center
Status: Active
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Mansfield
Cleveland Clinic Cancer Center Mansfield
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sandusky
North Coast Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: Active
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
Mercy Hospital Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Kaiser Permanente Northwest
Status: Active
Contact: Site Public Contact
Phone: 503-335-2400
Email: information@kpchr.org
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu

Pennsylvania

Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Easton
Easton Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 610-250-4000
Ephrata
Ephrata Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 717-721-4840
Gettysburg
Adams Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: Active
Contact: Site Public Contact
Phone: 570-459-2901
Email: HemonCCTrials@geisinger.edu
Lebanon
Sechler Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 717-741-8303
Email: doxenberg@wellspan.org
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-474-9892
Phoenixville
Phoenixville Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-983-1908
Pottsville
Geisinger Cancer Services-Pottsville
Status: Active
Contact: Site Public Contact
Phone: 800-275-6401
Email: HemonCCTrials@geisinger.edu
Reading
Penn State Health Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 610-378-2336
Email: dward1@pennstatehealth.psu.edu
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Williamsport
UPMC Susquehanna
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-598-4282
York
WellSpan Health-York Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957

South Carolina

Easley
Greenville Health System Cancer Institute-Easley
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville
Greenville Health System Cancer Institute-Butternut
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Saint Francis Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Saint Francis Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Greenwood
Self Regional Healthcare
Status: Active
Contact: Site Public Contact
Phone: 864-725-4771
Email: nmcgaha@selfregional.org
Greer
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

South Dakota

Aberdeen
Avera Cancer Institute-Aberdeen
Status: Active
Contact: Site Public Contact
Phone: 605-622-8700
Email: oncregulatory@avera.org
Rapid City
Rapid City Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 605-716-3982
Email: research@rcrh.org
Sioux Falls
Avera Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 888-634-7268
Email: oncregulatory@avera.org
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org
Nashville
Meharry Medical College
Status: Active
Contact: Site Public Contact
Phone: 615-341-4716
Email: Nancy.McCullough@NashvilleHA.org

Texas

San Antonio
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu

Virginia

Fishersville
Augusta Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 540-245-7106

West Virginia

Charleston
West Virginia University Charleston Division
Status: Active
Contact: Site Public Contact
Phone: 304-388-9944

Wisconsin

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay Oncology at Saint Vincent Hospital
Status: Active
Contact: Brian Leslie Burnette
Phone: 920-433-8889
Green Bay Oncology Limited at Saint Mary's Hospital
Status: Active
Contact: Brian Leslie Burnette
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Mayo Clinic Health System-Franciscan Healthcare
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
William S Middleton VA Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-256-1901ext17007
Manitowoc
Holy Family Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 920-320-2749
Marinette
Aurora Bay Area Medical Group-Marinette
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Aurora Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To develop a high-quality clinical database containing clinical history, including environmental exposure history, presenting signs and symptoms, diagnostic testing results, co-existing diseases, therapies and response to therapies, disease progression, quality of life and survival.

II. To develop a high-quality biorepository linked to the clinical data that will facilitate diverse studies, including genetic, epigenetic, immunologic, proteomic, and cell-functional and cell-phenotypic studies through the development of: central communication with the biorepository to ensure timely and accurate collections and biospecimen data appended to the clinical database; defined standard operating procedures for the collection, processing, storage and distribution, with special emphasis on processing protocols fit-for-purpose to sample requirements for downstream testing; and quality management procedures to ensure minimal numbers of errors in the management of the biospecimens.

III. To facilitate broad use of these linked data and specimens to support studies focused on: improving diagnostic accuracy, risk-stratification and prognostication, and medical decision-making in MDS; understanding quality of life and its relationship to changing disease and treatment status; understanding the pathogenesis of MDS and diverse MDS subtypes, including genetic, epigenetic, immunologic mechanisms; optimizing treatment strategies for specific subtypes of MDS; identifying novel biomarkers for MDS outcomes; and identifying novel targets for therapeutic interventions in MDS.

SECONDARY OBJECTIVES:

I. Detecting improved prognostic factors in low risk MDS. (Potential Studies)

II. Detecting markers of improved response to hypomethylating therapy. (Potential Studies)

III. Quality of life (QOL) and anemia therapy. (Potential Studies)

IV. Genetic factors in patients with complex karyotype. (Potential Studies)

V. Prognostic significance of splicing factor 3b subunit 1 (SF3B1) in MDS patients with refractory anemia with ring sideroblasts (RARS). (Potential Studies)

OUTLINE:

Patients undergo blood, bone marrow, eyebrow hairs, and buccal swab. Patients' medical records, baseline laboratory tests, quality of life, and diagnostic information including pathology reports and treatment history are also reviewed.

After the baseline visit, patients are followed up every 6 months. Follow up visits include disease evaluation, physical examination and collection of peripheral blood sample. Bone marrow biopsy and aspiration is performed when clinically necessary. Patients also complete the MDS-specific Qualify of Life in Myelodysplasia Scale (QUALMS), Functional Assessment of Cancer Therapy-General (FACT-G) (version 4), the Patient Reported Outcome Measurement Information System (PROMIS) Short Form version 1.0-Fatigue 7a, and the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Observational

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Mikkael Aaron Sekeres

Trial IDs

Primary ID NHLBI-MDS
Secondary IDs NCI-2016-00281
Clinicaltrials.gov ID NCT02775383