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

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.

Study Overview

• Status: Unknown
• Conditions: Cystectomy; Benign Cysts Ovarian; 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jacqueline Searcy; Phone Number: 4758 312-227; Email: FertilityPreservationMB@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H Lurie Childrens Hospital
      • Contact: Jacqueline Searcy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient recruitment could occur in either the pediatric surgery outpatient clinic or during hospital admission depending on the underlying condition and urgency of the procedure.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Cysts
• Other Study ID Numbers: 2017-726

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No