Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 107
- 主要终点
- Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 29 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls
时间窗: 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
时间窗: 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
时间窗: Baseline up to end of chemotherapy
Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
次要结局
- Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms(At enrollment (or diagnosis) and Day 5 post enrollment)
- Rate of AOF(Up to 12 months)