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NCT04717349Recruiting

Data Collection Study of Pediatric and Adolescent Gynecology Conditions

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

Background: Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions. Objective: To create a database about child and teenage gynecologic conditions. Eligibility: Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members Design: Participants will be screened with a review of their medical records. Participants may have a medical history and physical exam. Participants will have blood drawn using a needle. The blood will be used for genetic tests. Participants will have saliva collected. They will spit into a small plastic container. Or their spit will be absorbed from their mouth using a small sponge. The saliva will be used for genetic tests. Participants may have samples collected from their vagina. A small cotton swab will be used to gather the samples. This procedure is optional. If participants have a surgery related to their condition, a small tissue sample will be taken. It will be stored for future research. Participants may complete optional surveys. These surveys ask about their physical and emotional health. They can choose not to answer any of the questions. Researchers will collect medical data from participants standard tests. Such tests may include blood and urine tests, X-rays, nuclear medicine scans, and other tests. Data will also be collected from standard treatments they may receive.

Status (registry)
Recruiting
Study type
Observational
Enrollment
11000 (estimated)
First submitted
20 Jan 2021
Start date
21 Apr 2021
Primary completion date
2 Dec 2039
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NCT number
NCT04717349

What you commit to

  • Study type: Observational
  • Planned participants: 11000
  • From 21 Apr 2021 to the primary completion date, 2 Dec 2039
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Pregnant family members

Who the study is looking for

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 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.

Criteria the registry did not label

  • INCLUSION CRITERIA FOR PAG PATIENTS:
    • Provision of signed and dated informed consent form.
    • Stated willingness to comply with all study procedures and availability for the duration of the study.
    • Participants with known or suspected pediatric and adolescent gynecologic conditions of any age are eligible for this protocol.

Age in the registry: 1 day to 100 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.