laboratory biomarker analysis
OtherCorrelative studies
NCT Number: NCT01793233
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.
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Notify MeUp to 29 year
Female
Observational
CancerCare Manitoba, Winnipeg, Manitoba, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Correlative studies
Ancillary studies
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.
Time frame: Baseline up to end of chemotherapy
Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.
Time frame: Up to 12 months
Generalized estimating equation (GEE) will be used to model the change as a function of time.
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.
Time frame: At enrollment (or diagnosis) and Day 5 post enrollment
Describe the number of samples collected.
Children's Oncology Group
Network
Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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