Benign Cysts OvarianOTBNCT04118712
Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age
An observational study of Benign Cysts Ovarian and Cystectomy, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Cysts Ovarian, Cystectomy, Torsion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H Lurie Childrens Hospital
Chicago, Illinois, 60611
Jacqueline Searcy
About this study
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.
Read the 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.
- Conditions
- Benign Cysts Ovarian, Cystectomy, Torsion, Malignant Cysts Ovarian
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: October 2016- December 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start18 Oct 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Cysts OvarianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Rowell, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Erin Rowell, MD, Study director, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118712
- Sponsor's protocol ID
- 2017-726
- Acronym
- OTB
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2019
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No