Status:
RECRUITING
Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)
Lead Sponsor:
Erin Rowell
Conditions:
Pediatric Cancer
Eligibility:
FEMALE
Up to 30 years
Brief Summary
The purpose of this study is to safely remove ovarian tissue in pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and h...
Detailed Description
Participants are invited to take part in this study because they will be treated with chemotherapy, radiation and/or surgery that will likely affect the child's ovaries and cause the child to become i...
Eligibility Criteria
Inclusion
- Post-pubertal individuals \< 30 years of age
- Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation≥ 10Gy in post-pubertal girls or ≥15 Gy in pre- pubertal girls
- total body irradiation, and
- alkylating-intensive chemotherapy
- cyclophosphamide cumulative dose ≥7.5 g/m2
- any treatment regimen containing procarbazine
- busulfan cumulative dose \>600 mg/m2
- alkylating chemotherapy conditioning prior to stem cell transplantation
- combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation
- cranial radiation ≥30 Gy
- summed alkylating agent dose score ≥3 (Green et al., 2009)
- cyclophosphamide equivalent dose (CED) ≥ 4,000 mg/m2 (Green et al., 2014)
- Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. However, these patients will be required to provide a 4mm punch biopsy of their tissue for research.
Exclusion
- Patients with no anticipated oncologic therapies
- Pregnant children
- Children with one ovary
- Children deemed high risk for perioperative complications
- Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2035
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05309746
Start Date
November 1 2017
End Date
January 1 2035
Last Update
November 18 2024
Active Locations (1)
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1
Ann &Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60611