Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Natural history/EpidemiologyActive21 and under at diagnosis, any age at study entryNCI, OtherALTE03N1
NCI-2011-03822, COG-ALTE03N1, CDR0000360708, U10CA095861, U10CA180886, NCT00082745

Trial Description

Summary

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Further Study Information

PRIMARY OBJECTIVES:

I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.

V. To explore the role and nature of gene-environment interaction in the development of key adverse events.

OUTLINE:

DNA and RNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.

Eligibility Criteria

Inclusion Criteria:

  • ELIGIBILITY CRITERIA - CASES
  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • Development of one of the following key adverse events at any time following initiation of cancer therapy:
  • Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
  • Ischemic stroke (IS)
  • Subsequent malignant neoplasm (SMN)
  • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
  • Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  • ELIGIBILITY CRITERIA - CONTROLS
  • CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • CONTROLS: No clinical evidence of any of the following key adverse events:
  • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
  • Myocardial infarction (MI)
  • Ischemic stroke (IS)
  • Avascular necrosis (AVN)
  • Subsequent malignant neoplasm (SMN)
  • CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements
  • CONTROLS: Written informed consent from the patient and/or the patient's legally authorized guardian
  • CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Smita Bhatia, MD MPH, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama at University of Alabama at Birmingham

Alyssa T Reddy
Ph: 205-934-0309

Arkansas
Little Rock

Arkansas Children's Hospital at the University of Arkansas for Medical Sciences

David L Becton
Ph: 501-364-7373

California
Downey

Southern California Permanente Medical Group

Robert M Cooper
Ph: 626-564-3455

Los Angeles

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Jonsson Comprehensive Cancer Center at UCLA

Pamela H Kempert
Ph: 310-825-6708

Mattel Children's Hospital at UCLA

Pamela H Kempert
Ph: 310-825-6708

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Oakland

Children's Hospital and Research Center Oakland

Carla B Golden
Ph: 510-450-7600

Kaiser Permanente-Oakland

Steven K Bergstrom
Ph: 626-564-3455

Palo Alto

Lucile Packard Children's Hospital at Stanford University Medical Center

Neyssa M Marina
Ph: 650-498-7061
Email: clinicaltrials@med.stanford.edu

San Diego

Rady Children's Hospital - San Diego

William D Roberts
Ph: 858-966-5934

Colorado
Aurora

Children's Hospital Colorado Center for Cancer and Blood Disorders

Kelly W Maloney
Ph: 720-777-6672

Connecticut
Hartford

Connecticut Children's Medical Center

Michael S Isakoff
Ph: 860-545-9981

New Haven

Yale Cancer Center

Nina S Kadan-Lottick
Ph: 203-785-5702

Delaware
Wilmington

Alfred I. duPont Hospital for Children

Christopher N Frantz
Ph: 302-651-5755

District of Columbia
Washington

Children's National Medical Center

Jeffrey S Dome
Ph: 202-884-2549

Florida
Fort Myers

Children's Hospital of Southwest Florida

Emad K Salman
Ph: 239-343-5333

Gainesville

UF Health Cancer Center

William B Slayton
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

Jacksonville

Nemours Children's Clinic

Scott M Bradfield
Ph: 904-697-3529

Miami

Baptist-South Miami Regional Cancer Program

Doured Daghistani
Ph: 800-599-2456
Email: cancerinfo@baptisthealth.net

Miami Children's Hospital

Enrique A Escalon
Ph: 305-662-8360

Orlando

Nemours Children's Hospital

Ramamoorthy Nagasubramanian
Ph: 407-650-7150

Pensacola

Nemours Children's Clinic - Pensacola

Jeffrey H Schwartz
Ph: 904-697-3529

Saint Petersburg

All Children's Hospital

Gregory A Hale
Ph: 727-767-2423
Email: HamblinF@allkids.org

Tampa

St. Joseph's Children's Hospital of Tampa

Hardeo K Panchoosingh
Ph: 800-882-4123

Georgia
Atlanta

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Glen Lew
Ph: 404-785-1112

Augusta

Medical College of Georgia Cancer Center

Colleen H McDonough
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Robert W Wilkinson
Ph: 808-983-6090

Idaho
Boise

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Eugenia Chang
Ph: 800-845-4624

Illinois
Chicago

Ann and Robert H. Lurie Children's Hospital of Chicago

David O Walterhouse
Ph: 773-880-4562

University of Chicago Cancer Research Center

Susan L Cohn
Ph: 773-834-7424

University of Illinois Cancer Center

Mary L Schmidt
Ph: 312-355-3046

Oak Lawn

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Ammar Hayani
Ph: 800-323-8622

Peoria

Saint Jude Midwest Affiliate

Karen S Fernandez
Ph: 309-655-3258

Indiana
Indianapolis

Riley's Children Cancer Center at Riley Hospital for Children

Robert J Fallon
Ph: 317-274-2552

St. Vincent Indianapolis Hospital

Bassem I Razzouk
Ph: 317-338-2194

Iowa
Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Ayman A El-Sheikh
Ph: 800-237-1225

Kentucky
Lexington

University of Kentucky Chandler Medical Center

Lars M Wagner
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

Kenneth G Lucas
Ph: 866-530-5516

Louisiana
New Orleans

Children's Hospital of New Orleans

Lolie C Yu
Ph: 504-894-5377

Michigan
Ann Arbor

C.S. Mott Children's Hospital at University of Michigan Medical Center

Raymond J Hutchinson
Ph: 800-865-1125

Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Hadi Sawaf
Ph: 313-343-3166

East Lansing

Breslin Cancer Center at Ingham Regional Medical Center

Renuka Gera
Ph: 517-975-9547

Flint

Hurley Medical Center

Susumu Inoue
Ph: 888-606-6556

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

David S Dickens
Ph: 616-267-1925

Kalamazoo

Bronson Methodist Hospital

Jeffrey S Lobel
Ph: 800-227-2345

Western Michigan University School of Medicine Clinics

Jeffrey S Lobel
Ph: 800-227-2345

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Bruce C Bostrom
Ph: 612-813-5193

Masonic Cancer Center at University of Minnesota

Joseph P Neglia
Ph: 612-624-2620

Rochester

Mayo Clinic Cancer Center

Carola A. S. Arndt
Ph: 507-538-7623

Mississippi
Jackson

University of Mississippi Cancer Clinic

Gail C Megason
Ph: 601-815-6700

Missouri
Columbia

Columbia Regional Hospital

Thomas W Loew
Ph: 573-882-7440

Kansas City

Children's Mercy Hospital

Maxine L Hetherington
Ph: 816-234-3265

Saint Louis

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Robert J Hayashi
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Nevada
Las Vegas

CCOP - Nevada Cancer Research Foundation

Nik Farahana N Rashid
Ph: 702-384-0013

Sunrise Hospital and Medical Center

Nik Farahana N Rashid
Ph: 702-384-0013

New Jersey
Hackensack

Hackensack University Medical Center Cancer Center

Michael B Harris
Ph: 201-996-2879

New Brunswick

Saint Peter's University Hospital

Stanley Calderwood
Ph: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com

Newark

Newark Beth Israel Medical Center

Peri Kamalakar
Ph: 973-926-7230

Paterson

St. Joseph's Hospital and Medical Center

Mary A Bonilla
Ph: 973-754-2909

New Mexico
Albuquerque

University of New Mexico Cancer Center

Koh B Boayue
Ph: 505-272-6972

New York
Buffalo

Roswell Park Cancer Institute

Martin L Brecher
Ph: 877-275-7724

Mineola

Winthrop University Hospital

Mark E Weinblatt
Ph: 866-946-8476

New York

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Alice Lee
Ph: 212-305-8615

Stony Brook

Stony Brook University Cancer Center

Robert I Parker
Ph: 800-862-2215

Syracuse

SUNY Upstate Medical University Hospital

Karol H Kerr
Ph: 315-464-5476

Valhalla

New York Medical College

Jessica C Hochberg
Ph: 914-594-3794

North Carolina
Durham

Duke Cancer Institute

Susan G Kreissman
Ph: 888-275-3853

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Thomas W McLean
Ph: 336-713-6771

North Dakota
Fargo

Roger Maris Cancer Center at MeritCare Hospital

Samuel O Anim
Ph: 701-234-6161

Ohio
Akron

Akron Children's Hospital

Steven J Kuerbitz
Ph: 330-543-3193

Cincinnati

Cincinnati Children's Hospital Medical Center

John P Perentesis
Ph: 513-636-2799

Cleveland

Seidman Cancer Center at University Hospitals/Case Medical Center

Yousif (Joe) H Matloub
Ph: 216-844-5437

Columbus

Nationwide Children's Hospital

Mark A Ranalli
Ph: 614-722-2708

Dayton

Dayton Children's - Dayton

Emmett H Broxson
Ph: 800-228-4055

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Rene Y McNall-Knapp
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Oregon
Portland

Legacy Emanuel Children's Hospital

Janice F Olson
Ph: 503-413-2560

Legacy Emanuel Hospital and Health Center and Children's Hospital

Janice F Olson
Ph: 503-413-2560

Pennsylvania
Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip M Monteleone
Ph: 484-884-2201

Philadelphia

Children's Hospital of Philadelphia

Jill P Ginsberg
Ph: 215-590-2810

Children's Oncology Group

Smita Bhatia
Ph: 626-471-7321
Email: sbhatia@coh.org

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Jean M Tersak
Ph: 412-692-5573

PR
San Juan

San Jorge Children's Hospital

Luis A Clavell
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Carolina
Columbia

Palmetto Health South Carolina Cancer Center

Ronnie W. Neuberg
Ph: 803-434-3680

Greenville

BI-LO Charities Children's Cancer Center

Nichole L Bryant
Ph: 864-241-6251

Cancer Centers of the Carolinas - Faris Road

Cary E Stroud
Ph: 864-241-6251

South Dakota
Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Kayelyn J Wagner
Ph: 605-328-1367

Tennessee
Knoxville

East Tennessee Children's Hospital

Ray C Pais
Ph: 865-541-8266

Memphis

St. Jude Children's Research Hospital

Wayne L Furman
Ph: 866-278-5833
Email: info@stjude.org

Nashville

Vanderbilt-Ingram Cancer Center

Debra L Friedman
Ph: 800-811-8480

Texas
Corpus Christi

Driscoll Children's Hospital

M. C Johnson
Ph: 361-694-5311

Dallas

Medical City Dallas Hospital

Carl Lenarsky
Ph: 972-566-5588

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Patrick J Leavey
Ph: 214-648-7097

Fort Worth

Cook Children's Medical Center - Fort Worth

Mary Meaghan P Granger
Ph: 682-885-2103

Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

Karen R Rabin
Ph: 713-798-1354
Email: burton@bcm.edu

San Antonio

Methodist Children's Hospital of South Texas

Jaime Estrada
Ph: 210-575-7000

Temple

Scott and White Cancer Institute

Guy H Grayson
Ph: 254-724-5407

Utah
Salt Lake City

Primary Children's Medical Center

Phillip E Barnette
Ph: 801-585-5270

Vermont
Burlington

University of Vermont Cancer Center

Alan C Homans
Ph: 802-656-4101

Virginia
Falls Church

Inova Fairfax Hospital

Marshall A Schorin
Ph: 703-208-6650

Norfolk

Children's Hospital of The King's Daughters

Eric J Lowe
Ph: 757-668-7243

Roanoke

Carilion Medical Center for Children at Roanoke Community Hospital

Mandy M Atkinson
Ph: 540-981-7376

Washington
Seattle

Children's Hospital and Regional Medical Center - Seattle

K. S Baker
Ph: 800-422-6237

Spokane

Providence Cancer Center at Sacred Heart Medical Center

Judy L Felgenhauer
Ph: 800-228-6618
Email: HopeBeginsHere@providence.org

West Virginia
Charleston

West Virginia University Medical School - Charleston

Howard M Grodman
Ph: 304-388-9944

Wisconsin
Green Bay

St. Vincent Hospital Regional Cancer Center

John R Hill
Ph: 920-433-8889

Madison

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Kenneth B DeSantes
Ph: 608-262-5223

Milwaukee

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Bruce M. Camitta
Ph: 414-805-4380

Australia

Queensland
Herston

Royal Brisbane and Women's Hospital

Helen Irving
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Brisbane

Lady Cilento Children's Hospital

Helen Irving
Ph: 888-823-5923
Email: ctsucontact@westat.com

South Australia
North Adelaide

Women's and Children's Hospital

Maria L Kirby
Ph: (08) 8161 7327
Email: cywhs.oncsec@health.sa.gov.au

Victoria
Parkville

Royal Children's Hospital

Francoise M Mechinaud
Email: crdo.info@mcri.edu.au

Western Australia
Perth

Princess Margaret Hospital for Children

Catherine H Cole
Ph: (08) 9340 8222
Email: catherine.cole@health.wa.gov.au

Canada

Alberta
Edmonton

University of Alberta Hospital

Sunil Jayantilal S Desai
Ph: 780-407-6615
Email: val.taylor@albertahealthservices.ca

British Columbia
Vancouver

Children's and Women's Hospital of British Columbia

Caron Strahlendorf
Ph: 604-875-2345ext6477

Manitoba
Winnipeg

CancerCare Manitoba

Rochelle A Yanofsky
Ph: 866-561-1026
Email: CIO_Web@cancercare.mb.ca

Nova Scotia
Halifax

IWK Health Centre

Conrad V Fernandez
Ph: 902-470-8394

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Ph: 905-521-2100ext74595

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana P Silva
Ph: 613-544-2630

London

Children's Hospital of Western Ontario

Shayna M Zelcer
Ph: 519-685-8306

Quebec
Montreal

Hopital Sainte Justine

Yvan Samson
Ph: 514-345-4931

Saskatchewan
Saskatoon

Saskatoon Cancer Centre at the University of Saskatchewan

Christopher Mpofu
Ph: 306-655-2914

Switzerland

Geneva

Swiss Pediatric Oncology Group Geneva

Marc Ansari
Ph: 031 389 91 89

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00082745
ClinicalTrials.gov processed this data on April 02, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.