NCT05299710 Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)
| NCT ID | NCT05299710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erin Rowell |
| Condition | Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2018-05-29 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2018-05-29 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 fertility and hormone function.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Erin Rowell, MD
STUDY DIRECTOR
Lurie Childrens Hospital
Frequently Asked Questions
Who can join the NCT05299710 clinical trial?
This trial is open to female participants only, up to 11 Years, studying Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05299710 currently recruiting?
Yes, NCT05299710 is actively recruiting participants. Contact the research team at FertilityPreservation@luriechildrens.org for enrollment information.
Where is the NCT05299710 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05299710 clinical trial?
NCT05299710 is sponsored by Erin Rowell. The principal investigator is Erin Rowell, MD at Lurie Childrens Hospital. The trial plans to enroll 250 participants.
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