NCT01793233

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

Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 203 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: Female
• Age: 29 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Anaplastic Large Cell Lymphoma
• Burkitt Lymphoma
• Diffuse Large B-Cell Lymphoma
• Hodgkin Lymphoma
• Lymphoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2013-06-17
• Primary completion: 2022-12-31
• Completion: 2024-06-30
• First posted: 2013-02-15
• Last updated: 2024-08-26

Locations

107 sites across 2 countries: United States, Canada