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

Completed

• Conditions: Burkitt Lymphoma; Hodgkin Lymphoma; Lymphoma; Anaplastic Large Cell Lymphoma; Diffuse Large B-Cell Lymphoma
• Interventions: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

• Registration Number: NCT01793233
• Lead Sponsor: Children's Oncology Group

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 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.

Study Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Study Start: 2013-06-17
• Primary Completion: 2022-12-31
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

Inclusion Criteria

• Patients must have had first menses >= 6 months prior to enrollment
• Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma
• Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year
• Patients with any performance status are eligible for enrollment
• Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

• Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible
• Patients who have a secondary malignancy are not eligible
• Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible
• Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible
• Patients who previously have had their uterus or ovary(ies) removed are not eligible
• Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible
• Patients who are pregnant or breast feeding are not eligible
• Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (menstrual diary, biomarker analysis)	Questionnaire Administration	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.
Ancillary-Correlative (menstrual diary, biomarker analysis)	Laboratory 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.

Primary Outcome Measures

Name	Time	Method
Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls	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 recovery of AMH, FSH, and E2 in the post-therapy phase	Up to 12 months	Generalized estimating equation (GEE) will be used to model the change as a function of time.
Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline	Baseline up to end of chemotherapy	Evaluated using Wilcoxon signed rank test or a paired t-test after appropriate normalizing transformation.

Secondary Outcome Measures

Name	Time	Method
Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms	At enrollment (or diagnosis) and Day 5 post enrollment	Describe the number of samples collected.
Rate of AOF	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.

Trial Locations

Locations (107)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center; 🇺🇸 Downey, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Lucile Packard Children's Hospital Stanford University; 🇺🇸 Palo Alto, California, United States

Rady Children's Hospital - San Diego; 🇺🇸 San Diego, California, United States

UCSF Medical Center-Parnassus; 🇺🇸 San Francisco, California, United States

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