Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
a study on Lymphoma Diffuse Large B-Cell Lymphoma Non-Hodgkin Lymphoma Hodgkin's Lymphoma
Summary
- Eligibility
- for females ages up to 29 years (full criteria)
- Location
- at UCSF
- Dates
- study startedestimated completion
Description
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.
Official Title
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
Details
PRIMARY OBJECTIVES:
- 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:
- 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.
Keywords
Anaplastic Large Cell Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Hodgkin Lymphoma, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Laboratory Biomarker Analysis, Ancillary-Correlative (menstrual diary, biomarker analysis)
Eligibility
You can join if…
Open to females ages up to 29 years
- 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 CAN'T join 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
Locations
- UCSF Medical Center-Parnassus
San Francisco California 94143 United States - UCSF Medical Center-Mission Bay
San Francisco California 94158 United States - Rady Children's Hospital - San Diego
San Diego California 92123 United States - Children's Hospital of Orange County
Orange California 92868 United States - Kaiser Permanente Downey Medical Center
Downey California 90242 United States - Miller Children's and Women's Hospital Long Beach
Long Beach California 90806 United States - Lucile Packard Children's Hospital Stanford University
Palo Alto California 94304 United States - City of Hope Comprehensive Cancer Center
Duarte California 91010 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Children's Oncology Group
- ID
- NCT01793233
- Study Type
- Observational
- Participants
- About 203 people participating
- Last Updated