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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age
- ClinicalTrials.gov ID
- NCT04118712
- Acronym / sponsor ID
- OTB / 2017-726
- Conditions
- Benign Cysts Ovarian, Cystectomy, Torsion, Malignant Cysts Ovarian
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- Pre and Post Pubertal females
- Ages 0-18 years old
- Undergoing scheduled or emergent operative procedures involving the ovary
Key exclusion criteria (1 listed)
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Related trials for Benign Cysts Ovarian
Recruiting
Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts
Ovarian Cysts, Endometriosis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
Ovarian Cyst Benign
Active, not recruitingObservational study
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
Ovarian Cancer, Ovarian Cyst Benign
Recruiting
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
Benign Ovarian Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Rowell, MD study director
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Searcy (312-227 ext. 4758, FertilityPreservationMB@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Tissue Banking (time frame: October 2016- December 2030). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.