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NCT Number: NCT04118712

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

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.

Recruiting

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Key information

Conditions

Benign Cysts Ovarian Cystectomy Malignant Cysts Ovarian Torsion

Age range

Up to 18 year

Sex eligibility

Female

Study type

Observational

Primary location

Ann & Robert H Lurie Childrens Hospital

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Jacqueline Searcy

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ovarian Tissue Banking

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline Searcy

CONTACT

[email protected]

312-227 ext. 4758

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Acronym: OTB

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Oct 8, 2019
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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