Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
- Conditions
- Burkitt LymphomaHodgkin LymphomaLymphomaAnaplastic Large Cell LymphomaDiffuse Large B-Cell Lymphoma
- Interventions
- Other: Laboratory Biomarker AnalysisOther: Questionnaire Administration
- Registration Number
- NCT01793233
- Lead Sponsor
- Children's Oncology Group
- 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.
- Detailed Description
PRIMARY OBJECTIVES:
I. Compare anti mullerian hormone (AMH), follicle stimulating hormone (FSH), and estradiol (E2) between patients at baseline and cross section of controls and again between patients at 12 months off therapy and cross section of controls.
II. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.
III. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.
IV. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.
SECONDARY OBJECTIVES:
I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.
OUTLINE:
Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collection at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 203
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (menstrual diary, biomarker analysis) Questionnaire Administration 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. Ancillary-Correlative (menstrual diary, biomarker analysis) Laboratory 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.
- Primary Outcome Measures
Name Time Method Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls Up to 12 months 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.
Degree of recovery of AMH, FSH, and E2 in the post-therapy phase Up to 12 months Generalized estimating equation (GEE) will be used to model the change as a function of time.
Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline Baseline up to end of chemotherapy Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
- Secondary Outcome Measures
Name Time Method Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms At enrollment (or diagnosis) and Day 5 post enrollment Describe the number of samples collected.
Rate of AOF Up to 12 months Describe the number of patients with AOF as measured at 12 months by an FSH \> 40 divided by the total population.
Trial Locations
- Locations (107)
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
The Children's Hospital at TriStar Centennial
🇺🇸Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
🇺🇸Tampa, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Saint Luke's Cancer Institute - Boise
🇺🇸Boise, Idaho, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
UCSF Medical Center-Parnassus
🇺🇸San Francisco, California, United States
UCSF Medical Center-Mission Bay
🇺🇸San Francisco, California, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Golisano Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Nemours Children's Clinic-Jacksonville
🇺🇸Jacksonville, Florida, United States
Alfred I duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Kaiser Permanente Downey Medical Center
🇺🇸Downey, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Lurie Children's Hospital-Chicago
🇺🇸Chicago, Illinois, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Missouri Children's Hospital
🇺🇸Columbia, Missouri, United States
Saint Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Lucile Packard Children's Hospital Stanford University
🇺🇸Palo Alto, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Children's Healthcare of Atlanta - Egleston
🇺🇸Atlanta, Georgia, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Miller Children's and Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Nemours Children's Clinic - Pensacola
🇺🇸Pensacola, Florida, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
🇺🇸Las Vegas, Nevada, United States
Nevada Cancer Research Foundation NCORP
🇺🇸Las Vegas, Nevada, United States
C S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospitals and Clinics
🇺🇸Kansas City, Missouri, United States
NYP/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Legacy Emanuel Children's Hospital
🇺🇸Portland, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
🇺🇸Toledo, Ohio, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
East Tennessee Childrens Hospital
🇺🇸Knoxville, Tennessee, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Summerlin Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
🇨🇦Quebec, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Albany Medical Center
🇺🇸Albany, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Children's Hospital
🇨🇦London, Ontario, Canada
The Montreal Children's Hospital of the MUHC
🇨🇦Montreal, Quebec, Canada
Saint Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Sanford Broadway Medical Center
🇺🇸Fargo, North Dakota, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Rainbow Babies and Childrens Hospital
🇺🇸Cleveland, Ohio, United States
BI-LO Charities Children's Cancer Center
🇺🇸Greenville, South Carolina, United States
Centre Hospitalier Universitaire Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
T C Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
University of Kentucky/Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
Montefiore Medical Center - Moses Campus
🇺🇸Bronx, New York, United States
University of Wisconsin Carbone Cancer Center - University Hospital
🇺🇸Madison, Wisconsin, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States