RECRUITING

Testicular Tissue Cryopreservation in Children

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Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.

Official Title

Testicular Tissue Cryopreservation for Fertility Preservation in Males Facing Fertility Threatening Diagnoses or Treatment Regimens

Quick Facts

Study Start:2016-08-16
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02872532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 17 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Be male 0-17 years of age.
  2. 2. Meet at least one of the following four conditions:
  3. 3. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.
  4. 4. Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
  5. 5. Consent for serum screening tests for infectious diseases to be performed at the time of testicular tissue harvesting. The immediate testing will include but not be limited to testing for Hepatitis B, Hepatitis C, and HIV.
  6. 6. Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
  1. 1. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  2. 2. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
  3. 3. Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.

Contacts and Locations

Principal Investigator

Candace F. Granberg, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Candace F. Granberg, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-16
Study Completion Date2025-12

Study Record Updates

Study Start Date2016-08-16
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer