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

Recruiting

• Conditions: Benign Cysts Ovarian; Torsion; Malignant Cysts Ovarian; Cystectomy

• Registration Number: NCT04118712
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10-18
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovarian Tissue Banking	October 2016- December 2030	The primary purpose of this study is analyzing the histologically ovarian tissue obtained surgically due to different ovarian pathologies. The tissue will be stained and follicles of varying stages will be counted and compared for different patient ages and ovarian pathologies. The extra-cellular matrix will also be stained and compared between different patient ages and ovarian pathologies.

Trial Locations

Locations (1)

Ann & Robert H Lurie Childrens Hospital; 🇺🇸 Chicago, Illinois, United States