An observational study in Anaplastic Large Cell Lymphoma, Burkitt Lymphoma and Diffuse Large B-Cell Lymphoma, sponsored by Children's Oncology Group. Completed at 107 sites in 2 countries. Open to female participants aged Up to 29 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Children's Oncology Group · Observational
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.
228 studies on the registry are indexed under Lymphoma, Large-Cell, Anaplastic; 27 are open to participants now.
This study's enrollment of 203 is close to the median of 202 across 18 observational studies indexed under Lymphoma, Large-Cell, Anaplastic.
Browse Lymphoma, Large-Cell, Anaplastic studies →Children's Oncology Group is the lead sponsor of 447 studies on the registry; 35 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with newly diagnosed lymphoma at Children's Oncology Group
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Correlative studies
Ancillary studies
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
Showing the first 100 of 107 sites across 2 countries.
Ran from Jun 2013 to primary completion in Dec 2022, 114 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Lymphoma, Large-Cell, Anaplastic →