Clinical Trial: Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

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 cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

Detailed Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome: Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls [ Time Frame: 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.


Original Primary Outcome: Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of healthy controls [ Time Frame: 12 months post therapy ]

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.


Current Secondary Outcome:

  • Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline [ Time Frame: Baseline up to end of chemotherapy ]
    Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
  • Degree of recovery of AMH, FSH, and E2 in the post-therapy phase [ Time Frame: Up to 12 months ]
    Generalized estimating equation (GEE) will be used to model the change as a function of time.
  • Rate of AOF [ Time Frame: Up to 12 months ]


Original Secondary Outcome:

  • Describe acute ovarian failure (AOF) prevalence 12 months post-therapy [ Time Frame: 12 months post therapy ]
    Describe the rate of acute ovarian failure (amenorrhea plus FSH and E2) at 12 months post-therapy. With 195-205 enrolled case patients the uncertainty in the estimates of the ovarian failure rate at 12 months post-therapy would be at most ± 5%.
  • Degree of recovery of AMH, FSH, and E2 in the post-therapy phase [ Time Frame: 12 months post therapy ]
    Generalized estimating equation (GEE) will be used to model the change as a function of time.
  • Rate of AOF [ Time Frame: 12 months post therapy ]


Information By: Children's Oncology Group

Dates:
Date Received: February 13, 2013
Date Started: June 2013
Date Completion: June 2019
Last Updated: May 5, 2017
Last Verified: May 2017