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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT04118712

Collaborator

(none)

100

Enrollment

Location

74.4

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Cysts Ovarian Cystectomy Torsion Malignant Cysts Ovarian

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 18, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Outcome Measures

Primary Outcome Measures

Ovarian Tissue Banking [October 2016- January 2023]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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

Exclusion Criteria:

Pregnant females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ann & Robert H Lurie Childrens Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

Study Director: Erin Rowell, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ann & Robert H Lurie Children's Hospital of Chicago

ClinicalTrials.gov Identifier:

NCT04118712

Other Study ID Numbers:

2017-726

First Posted:

Oct 8, 2019

Last Update Posted:

Jan 6, 2020

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cysts

Study Results

No Results Posted as of Jan 6, 2020