Collecting data on gynecologic conditions in children and adolescents
Official title: Data Collection Study of Pediatric and Adolescent Gynecology Conditions
Run by National Institutes of Health Clinical Center (CC) · NCT04717349 · Data updated 2026-11-12
This study is collecting information from children and teens with gynecologic conditions to better understand these issues and improve future care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 100 Years |
| Sex | All |
| Enrollment | 11000 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | April 21, 2021 |
| Main results expected | December 2, 2039 |
| Study ends | December 2, 2039 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT04717349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children and adolescents with known or suspected gynecologic conditions, as well as their adult family members.
✕Probably not a fit
Patients without any known or suspected pediatric and adolescent gynecologic conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather comprehensive data over time from a diverse group of young individuals with known or suspected pediatric and adolescent gynecologic conditions. Participants will undergo medical record reviews, physical exams, and genetic testing through blood and saliva samples. The goal is to create a large database that captures the variety and presentation of these conditions to enhance understanding and improve future care.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for pediatric and adolescent gynecologic conditions.
How similar studies have gone: While this approach is focused on data collection, similar studies have shown success in enhancing understanding of pediatric conditions through comprehensive databases.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA FOR PAG PATIENTS: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Participants with known or suspected pediatric and adolescent gynecologic conditions of any age are eligible for this protocol. INCLUSION CRITERIA FOR PAG PATIENTS OF FAMILY MEMBERS: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. In order to be eligible to participate in this study, an individual must meet all of the following criteria: Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient, will exclude participation. Patients who are critically ill, unstable, or with severe organ failure that may affect/limit the evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded. 2. Pregnant family members
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Veronica Gomez-Lobo, M.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study coordinator: Veronica Gomez-Lobo, M.D.
- Email: veronica.gomez-lobo@nih.gov
- Phone: (301) 435-7567
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.