Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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: 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

Exclusion Criteria:

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 is for people with:

Ovarian Cancer

Estimated Enrollment:

203

Study ID:

NCT01793233

Recruitment Status:

Active, not recruiting

Sponsor:

Children's Oncology Group

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There are 106 Locations for this study

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Children's Hospital of Alabama
Birmingham Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, 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 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
Saint 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
Helen DeVos Children's Hospital at Spectrum Health
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
Columbia Regional
Columbia Missouri, 65201, 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, 87102, United States
Albany Medical Center
Albany New York, 12208, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Winthrop Hospital
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
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
Madison Wisconsin, 53792, United States
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada
Kingston Health Sciences Centre
Kingston Ontario, K7L 2, Canada
Children's Hospital
London Ontario, N6A 5, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
The Montreal Children's Hospital of the MUHC
Montreal Quebec, H3H 1, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal Quebec, H3T 1, Canada
Centre Hospitalier Universitaire de Quebec
Quebec , G1V 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

203

Study ID:

NCT01793233

Recruitment Status:

Active, not recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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