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

Completed

• Conditions: Anaplastic Large Cell Lymphoma; Burkitt Lymphoma; Diffuse Large B-Cell Lymphoma; Hodgkin Lymphoma; Lymphoma

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-2-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients must have had first menses >= 6 months prior to enrollment<br><br> - Patients must be newly diagnosed with lymphoma; this includes but is not limited to<br> Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic<br> large cell lymphoma<br><br> - Planned cancer treatment must include an alkylating agent: i.e. procarbazine,<br> cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year<br><br> - Patients with any performance status are eligible for enrollment<br><br> - Patients may take hormone medications excluding gonadotropin-releasing hormone<br> (GnRH) analogues<br><br> - All patients and/or their parents or legal guardians must sign a written informed<br> consent<br><br> - All institutional, Food and Drug Administration (FDA), and National Cancer Institute<br> (NCI) requirements for human studies must be met<br><br>Exclusion Criteria:<br><br> - Patients who have previously received chemotherapy other than steroids and<br> intrathecal chemotherapy are not eligible<br><br> - Patients who have a secondary malignancy are not eligible<br><br> - Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic<br> ovarian syndrome are not eligible<br><br> - Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic<br> irradiation, cranial irradiation or hematopoietic stem cell transplantation are not<br> eligible<br><br> - Patients who previously have had their uterus or ovary(ies) removed are not eligible<br><br> - Patients who have received gonadotropin release hormone agonist or antagonist (e.g.<br> Lupron) prior to study entry are not eligible<br><br> - Patients who are pregnant or breast feeding are not eligible<br><br> - Patients who have undergone or are planning to undergo ovarian tissue, oocyte or<br> embryo cryopreservation prior to treatment are not eligible

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of change in AMH, FSH, and E2 defined as the ratio of baseline minus end of therapy (EOT) measurement over baseline;Degree of recovery of AMH, FSH, and E2 in the post-therapy phase;Comparison of the measures of ovarian reserve (AMH, FSH and E2) to that of health controls

Secondary Outcome Measures

Name	Time	Method
Rate of AOF;Collect blood samples for future evaluation of drug metabolizing Describe number of samples enzyme polymorphisms