Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
5 other identifiers
observational
203
2 countries
107
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Longer than P75 for all trials
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedStudy Start
First participant enrolled
June 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedAugust 26, 2024
August 1, 2024
9.5 years
February 13, 2013
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls
Compared using the Wilcoxon rank-sum test or the two sample t-test after appropriate transformation. Analysis of covariance will be used to adjust these comparisons for covariates including age, race, dose of alkylating agent and use of hormone medications.
Up to 12 months
Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline
Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
Baseline up to end of chemotherapy
Degree of recovery of AMH, FSH, and E2 in the post-therapy phase
Generalized estimating equation (GEE) will be used to model the change as a function of time.
Up to 12 months
Secondary Outcomes (2)
Rate of AOF
Up to 12 months
Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms
At enrollment (or diagnosis) and Day 5 post enrollment
Study Arms (1)
Ancillary-Correlative (menstrual diary, biomarker analysis)
Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collections at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.
Interventions
Correlative studies
Ancillary studies
Eligibility Criteria
Patients with newly diagnosed lymphoma at Children's Oncology Group
You may qualify if:
- 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: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year
- Patients with any performance status are eligible for enrollment
- Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
You may not qualify if:
- Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible
- Patients who have a secondary malignancy are not eligible
- Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (107)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri Children's Hospital
Columbia, Missouri, 65212, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89169, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Albany Medical Center
Albany, New York, 12208, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
New York Medical College
Valhalla, New York, 10595, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Children's Hospital
London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, G1V 4G2, Canada
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer M Levine
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2013
First Posted
February 15, 2013
Study Start
June 17, 2013
Primary Completion
December 31, 2022
Study Completion
June 30, 2024
Last Updated
August 26, 2024
Record last verified: 2024-08