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.
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.
Study Type
OBSERVATIONAL
Enrollment
203
Correlative studies
Ancillary studies
Children's Hospital of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls
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.
Time frame: Up to 12 months
Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline
Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
Time frame: Baseline up to end of chemotherapy
Degree of recovery of AMH, FSH, and E2 in the post-therapy phase
Generalized estimating equation (GEE) will be used to model the change as a function of time.
Time frame: Up to 12 months
Rate of AOF
Describe the number of patients with AOF as measured at 12 months by an FSH \> 40 divided by the total population.
Time frame: Up to 12 months
Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms
Describe the number of samples collected.
Time frame: At enrollment (or diagnosis) and Day 5 post enrollment
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