GnRHA Therapy and Ovarian Preservation in Pediatric Cancer Patient

NCT02677311 | Terminated

• 1 other identifier: 15-0596-F2L
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective case control study. Participants will be enrolled as case subjects or control subjects, depending upon the gonadotoxicity of their chemoradiation therapy. The chemotherapeutic regimens will be determined per standard of care. Participants will receive GnRHa (Lupron) as standard of care for menstrual suppression. Blood draws and pelvic ultrasound at baseline, 6 months and 12 months post completion of chemotherapy are the interventions. The duration of the study will be approximately 12 months.The study time includes the time necessary for completion of most cancer treatments in this population, which approximates 8-12 months, and time to allow complete excretion of the Lupron from the systemic circulation with reliable testing of the hypothalamic pituitary ovarian (H-P-O) axis. The results of the study will be used to guide a larger study evaluating the efficacy of gonadotropin releasing hormone agonist (GnRHa) as ovarian preservation therapy in young subjects receiving chemoradiation.

Conditions

Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (6)

• Ovarian Reserve - AMH

  Assess AMH change from baseline to 6 months.

  6 months post completion of chemotherapy

• Ovarian Reserve - AMH

  Assess AMH change from baseline to 12 months.

  12 months post completion of chemotherapy

• Ovarian Reserve - Menstrual function

  Assess menstrual function change from baseline to 12 year.

  12 months post completion of chemotherapy

• Ovarian Reserve - FSH

  Assess FSH change from baseline to 6 months.

  6 months post completion of chemotherapy

• Ovarian Reserve - FSH

  Assess FSH change from baseline to 12 months.

  12 months post completion of chemotherapy

• Ovarian Reserve - Menstrual function

  Assess menstrual function change from baseline to 6 months.

  6 months post completion of chemotherapy

Secondary Outcomes (1)

• Ovarian Reserve - Agreement of AMH and AFC

  Pre-GnRHa therapy, 6 months post and 12 post completion of chemotherapy

Study Arms (2)

Cases

OTHER

Participants who will receive gonadotoxic chemoradiation therapies to include the alkylating agents, heavy metals and plant alkaloids as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.

Procedure: Blood draw; Procedure: Pelvic Ultrasound

Controls

OTHER

Participants who will receive chemoradiation therapies presumed to be low risk for gonadotoxicity as determined by the literature and the patient's oncolologist as a standard part of their cancer treatment. Participants will also receive the GnRHa for menstrual suppression as part of standard of care. Baseline blood draws and pelvic ultrasound will be the intervention. Repeat blood draws and pelvic ultrasound at 6 and 12 months will also be interventions.

Procedure: Blood draw; Procedure: Pelvic Ultrasound

Interventions

Blood draw PROCEDURE

Blood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion

Cases; Controls

Pelvic Ultrasound PROCEDURE

Pelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion

Cases; Controls

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Receiving chemoradiation therapy
• Documented ovarian function
• Require menstrual suppression with GnRHa during chemoradiation therapy
• Patients at the University of Kentucky, Norton Healthcare or Cincinnati Children's Hospital Medical Center

You may not qualify if:

• Under 8 years of age and older than 19 years of age
• Male
• Unable to provide consent or assent

Sponsors & Collaborators

• University of Kentucky: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: February 9, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share