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

Cystectomy Clinical Trial

— OTB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118712
• Other study ID #: 2017-726
• Status: Recruiting
• Start date: October 18, 2016
• Est. completion date: January 2023

Study information

• Verified date: October 2019
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Jacqueline Searcy
• Phone: 312-227
• Email: FertilityPreservationMB[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Cysts Ovarian
• Cystectomy
• Cysts
• Malignant Cysts Ovarian
• Torsion

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Childrens Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian Tissue Banking	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.	October 2016- January 2023