Status:
COMPLETED
Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anaplastic Large Cell Lymphoma
Burkitt Lymphoma
Eligibility:
FEMALE
Up to 29 years
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 ...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01793233
Start Date
June 17 2013
End Date
June 30 2024
Last Update
August 26 2024
Active Locations (107)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
3
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010