Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Benign Cysts Ovarian, Cystectomy, Torsion, Malignant Cysts Ovarian. Basic parameters: up to 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Ovarian Tissue Banking [Time frame: October 2016- December 2030]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Ann & Robert H Lurie Childrens Hospital — Chicago
Identifiers
NCT: NCT04118712 · 2017-726