RECRUITING

Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

Conditions

Quick Navigation

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

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 hormone function.

Official Title

Ovarian Tissue Cryopreservation for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Diagnosis or Treatment Regimen

Quick Facts

Study Start:2017-11-01

Study Completion:2035-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05309746

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:Not specified to 30 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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)

Inclusion Criteria

Exclusion Criteria

* 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.

* 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)

Contacts and Locations

Study Contact

Sara Reyes

CONTACT

312-227-4145

FertilityPreservation@luriechildrens.org

Principal Investigator

Erin Rowell, MD

STUDY_DIRECTOR

Lurie Childrens Hospital

Study Locations (Sites)

Ann &Robert H Lurie Children's Hospital

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Erin Rowell

Erin Rowell, MD, STUDY_DIRECTOR, Lurie Childrens Hospital

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 Date2017-11-01

Study Completion Date2035-01

Study Record Updates

Study Start Date2017-11-01

Study Completion Date2035-01

Terms related to this study

Keywords Provided by Researchers

OTC
fertility

Additional Relevant MeSH Terms

Pediatric Cancer