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NCT Number: NCT01793233

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

Important dates

Study start
2013
Primary completion
2022
Study completion
2024
First posted
Feb 15, 2013
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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