Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age

NCT ID: NCT04118712

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-18

Study Completion Date

2030-12-31

Brief Summary

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A child is eligible to participate in this study because she is having surgery on her ovary. The investigators may obtain a sample of any discarded tissue from the surgery for an ovarian tissue library. This study is being conducted to understand how common ovarian conditions effect the number and quality of ovarian follicles and the reproductive potential of the ovary.

Detailed Description

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The investigators intend to enroll 100 girls and women in this study who are undergoing surgery involving the ovary. This may include patients with different conditions for comparison, such as ovarian cysts or masses and ovarian torsion. For each patient, the investigators will obtain the discarded tissue from the operating room after the affected ovarian tissue is resected. The tissue sample will only be taken for the tissue library from ovarian tissue that would otherwise be discarded.

No additional tissue will be collected other than that which is already removed as part of the ovarian procedure. No additional surgery or other procedures will be performed for the purposes of this study. The tissue will be assigned a study ID number and the age, gender and diagnosis of the child will be entered on the tissue library log and maintained for the duration of the study.

Conditions

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Benign Cysts Ovarian Cystectomy Torsion Malignant Cysts Ovarian

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Pre and Post Pubertal females
* Ages 0-18 years old
* Undergoing scheduled or emergent operative procedures involving the ovary

1. oophorectomy (torsion, benign mass/cyst, malignant mass/cyst)
2. ovarian cystectomy

Exclusion Criteria

* Pregnant females
Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Rowell, MD

Role: STUDY_DIRECTOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H Lurie Childrens Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacqueline Searcy

Role: CONTACT

312-227 ext. 4758

Facility Contacts

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Jacqueline Searcy

Role: primary

Other Identifiers

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2017-726

Identifier Type: -

Identifier Source: org_study_id

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