Status:
RECRUITING
Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
Lead Sponsor:
Erin Rowell
Collaborating Sponsors:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Cancers
Eligibility:
FEMALE
Up to 11 years
Brief Summary
The purpose of this study is to safely remove ovarian tissue in pre-pubertal pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fe...
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
- Pre- Pubertal Individual
- 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 ≥15Gy 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)
Exclusion
- Patients with no anticipated oncologic therapies
- Post-pubertal individuals
- 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 :
May 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2035
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05299710
Start Date
May 29 2018
End Date
January 1 2035
Last Update
November 18 2024
Active Locations (1)
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1
Ann & Robert H Lurie Childrens Hospital
Chicago, Illinois, United States, 60611