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Data Collection Study of Pediatric and Adolescent Gynecology Conditions

NCT04717349 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 11000

Last updated 2026-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Disorders of Sex Development (DSD)
  • Pediatric and Adolescent Cancers of the Genital Tract
  • Reproductive Endocrine Conditions in Puberty
  • Structural Gynecologic Conditions Including Vulvar and Vaginal Conditions

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Veronica Gomez-Lobo, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
1 Day
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2039-12-02
Completion
2039-12-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04717349 on ClinicalTrials.gov