NCT04118712

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
56mo left

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Oct 2016Dec 2030

Study Start

First participant enrolled

October 18, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

14.1 years

First QC Date

October 4, 2019

Last Update Submit

November 14, 2024

Conditions

Benign Cysts OvarianCystectomyTorsionMalignant Cysts Ovarian

Outcome Measures

Primary Outcomes (1)

  • 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- December 2030

Eligibility Criteria

AgeUp to 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Childrens Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ovarian tissue

Study Officials

  • Erin Rowell, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    STUDY DIRECTOR

Central Study Contacts

Jacqueline Searcy

CONTACT

312-227FertilityPreservationMB@luriechildrens.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 8, 2019

Study Start

October 18, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations

US(1)