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.
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.
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
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There are 106 Locations for this study
Birmingham Alabama, 35233, United States
Little Rock Arkansas, 72202, United States
Downey California, 90242, United States
Duarte California, 91010, United States
Loma Linda California, 92354, United States
Long Beach California, 90806, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
San Diego California, 92123, United States
San Francisco California, 94143, United States
San Francisco California, 94158, United States
Hartford Connecticut, 06106, United States
Wilmington Delaware, 19803, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33908, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33176, United States
Orlando Florida, 32827, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33701, United States
Tampa Florida, 33606, United States
Tampa Florida, 33607, United States
West Palm Beach Florida, 33407, United States
Atlanta Georgia, 30322, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96826, United States
Boise Idaho, 83712, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Grand Rapids Michigan, 49503, United States
Minneapolis Minnesota, 55404, United States
Jackson Mississippi, 39216, United States
Columbia Missouri, 65201, United States
Kansas City Missouri, 64108, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89109, United States
Las Vegas Nevada, 89135, United States
Las Vegas Nevada, 89144, United States
Las Vegas Nevada, 89169, United States
Hackensack New Jersey, 07601, United States
Livingston New Jersey, 07039, United States
Morristown New Jersey, 07960, United States
Newark New Jersey, 07112, United States
Albuquerque New Mexico, 87102, United States
Albany New York, 12208, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
Mineola New York, 11501, United States
New York New York, 10032, United States
New York New York, 10065, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Valhalla New York, 10595, United States
Asheville North Carolina, 28801, United States
Greenville North Carolina, 27834, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43205, United States
Toledo Ohio, 43606, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19134, United States
Pittsburgh Pennsylvania, 15224, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37403, United States
Knoxville Tennessee, 37916, United States
Memphis Tennessee, 38105, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78723, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98105, United States
Spokane Washington, 99204, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3K 6, Canada
Hamilton Ontario, L8N 3, Canada
Kingston Ontario, K7L 2, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3H 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec , G1V 4, Canada
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