Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
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|ClinicalTrials.gov Identifier: NCT01793233|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment|
|Anaplastic Large Cell Lymphoma Burkitt Lymphoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma Lymphoma||Other: Laboratory Biomarker Analysis Other: Questionnaire Administration|
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.
I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.
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|
|Estimated Enrollment :||205 participants|
|Official Title:||Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma|
|Actual Study Start Date :||June 17, 2013|
|Estimated Primary Completion Date :||December 30, 2019|
Ancillary-Correlative (menstrual diary, biomarker analysis)
Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collections at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
- 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.
- 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 ]Describe the number of patients with AOF as measured at 12 months by an FSH > 40 divided by the total population.
- Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms [ Time Frame: At enrollment (or diagnosis) and Day 5 post enrollment ]Describe the number of samples collected.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793233
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|Principal Investigator:||Jennifer M Levine||Children's Oncology Group|