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Clinical Trials (PDQ®)

Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Supportive careActive21 and underOtherALTE11C1
NCI-2013-00069, COG-ALTE11C1, NCT01793233

Trial Description

Summary

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

Further Study Information

The primary objectives of this study are to compare Anti Mullerian Hormone (AMH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) between patients (enrolled groupwide) at two timepoints (baseline and 12 months off therapy) and a cross section of controls (enrolled at limited institutions) and to describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

Eligibility Criteria

Inclusion Criteria:

  • Patients must have had first menses <= 6 months prior to enrollment
  • Patients must be newly diagnosed with lymphoma. This includes but is not limited to Hodgkin Lymphoma, Burkitts Lymphoma, Diffuse Large B Cell Lymphoma, and Anaplastic Large Cell Lymphoma.
  • Planned cancer treatment must include an alkylating agent: ie procarbazine, cyclophosphamide, ifosphamide. Planned cancer treatment must be less than one year.
  • Patients with any performance status are eligible for enrollment
  • Patients may take oral contraceptives

Exclusion Criteria:

  • Patients who have previously received chemotherapy other than steroids
  • Patients who have a secondary malignancy are not eligible
  • Patients with known history of ovarian disease: e.g. Turner Syndrome or Polycystic Ovarian Syndrome
  • Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible
  • Patients who previously have had their uterus or ovary(ies) removed are not eligible
  • Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible
  • Patients who are pregnant or breast feeding are not eligible
  • Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

Leukemia and Lymphoma Society

Jennifer M Levine, MD, MSWStudy Chair

Jennifer LevinePrincipal Investigator

Jennifer M Levine, MD, MSWPh: 212 305-5808
  Email: jl175@columbia.edu

Trial Sites

U.S.A.
California
  Duarte
 City of Hope Comprehensive Cancer Center
 Anna B Pawlowska Ph: 800-826-4673
  Email: becomingapatient@coh.org
  Long Beach
 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
 Amanda M Termuhlen Ph: 562-933-5437
  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
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Robert E Goldsby Ph: 877-827-3222
Connecticut
  Hartford
 Connecticut Children's Medical Center
 Michael S Isakoff Ph: 860-545-9981
Delaware
  Wilmington
 Alfred I. duPont Hospital for Children
 Christopher N Frantz Ph: 302-651-5755
Florida
  Fort Myers
 Children's Hospital of Southwest Florida
 Emad K Salman Ph: 239-343-5333
  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
  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
Georgia
  Atlanta
 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
 Marla H Daves Ph: 404-778-1868
  Email: burton@bcm.edu
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Eugenia Chang Ph: 800-845-4624
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Susan L Cohn Ph: 773-834-7424
Indiana
  Indianapolis
 Riley's Children Cancer Center at Riley Hospital for Children
 Robert J Fallon Ph: 317-274-2552
Iowa
  Des Moines
 Blank Children's Hospital
 Wendy L Woods-Swafford Ph: 515-241-6729
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Martha F Greenwood Ph: 859-257-3379
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Joseph M Wiley Ph: 410-601-6120
  Email: pridgely@lifebridgehealth.org
Michigan
  Detroit
 Wayne State University
 Meret Henry Ph: 313-576-9363
  Grand Rapids
 Helen DeVos Children's Hospital at Spectrum Health
 David S Dickens Ph: 616-267-1925
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail C Megason Ph: 601-815-6700
Nevada
  Las Vegas
 Cancer Institute of Nevada at Summerlin Hospital Medical Center
 Jonathan Bernstein Ph: 702-384-0013
 CCOP - Nevada Cancer Research Foundation
 Jonathan Bernstein Ph: 702-384-0013
 Children's Specialty Center of Nevada
 Jonathan Bernstein Ph: 702-384-0013
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Michael B Harris Ph: 201-996-2879
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Steven L Halpern Ph: 973-971-5900
  Newark
 Newark Beth Israel Medical Center
 Stacey Rifkin-Zenenberg Ph: 973-926-7230
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Koh B Boayue Ph: 505-272-6972
New York
  Bronx
 Montefiore Medical Center
 Peter D Cole Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Alice Lee Ph: 212-305-8615
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Krystal S Bottom Ph: 828-213-4150
  Greenville
 Leo W. Jenkins Cancer Center at ECU Medical School
 George E Hucks Ph: 252-744-2391
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Sharon M Castellino Ph: 336-713-6771
Ohio
  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
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene Y McNall-Knapp Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Philadelphia
 Children's Hospital of Philadelphia
 Jill P Ginsberg Ph: 215-590-2810
 Children's Oncology Group
 Jennifer M Levine Ph: 212-305-5808
  Email: ji175@columbia.edu
  Pittsburgh
 Children's Hospital of Pittsburgh of UPMC
 Peter H Shaw Ph: 412-692-5573
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: 901-595-4644
  Nashville
 Vanderbilt-Ingram Cancer Center
 Debra L Friedman Ph: 800-811-8480
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Naomi J Winick Ph: 214-648-7097
  San Antonio
 University of Texas Health Science Center at San Antonio
 Anne-Marie R Langevin Ph: 210-567-0653
  Email: che@uthscsa.edu
Virginia
  Norfolk
 Children's Hospital of The King's Daughters
 Eric J Lowe Ph: 757-668-7243
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Gita V Massey Ph: 804-628-1939
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Douglas S Hawkins Ph: 866-987-2000
Wisconsin
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Kenneth B DeSantes Ph: 608-262-5223
Canada
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
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Mariana P Silva Ph: 613-544-2630
Quebec
  Montreal
 Montreal Children's Hospital at McGill University Health Center
 Sharon B Abish Ph: 514-412-4445
  Email: info@thechildren.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01793233
ClinicalTrials.gov processed this data on November 14, 2013

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.

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