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NCT04717349 · ClinicalTrials.gov registry record
Data Collection Study of Pediatric and Adolescent Gynecology Conditions
A clinical trial of Disorders of Sex Development (DSD) and Pediatric and Adolescent Cancers of the Genital Tract, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- 11,000
- Enrollment target
- 1
- Study location
NCT04717349: Recruiting study of Disorders of Sex Development (DSD) and Pediatric and Adolescent Cancers of the Genital Tract, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT04717349 is a study of Disorders of Sex Development (DSD) and Pediatric and Adolescent Cancers of the Genital Tract that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 11,000 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04717349, a study of Disorders of Sex Development (DSD) and Pediatric and Adolescent Cancers of the Genital Tract, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- 11,000 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Recruit a diverse population of pediatric and adult subjects with known or suspected PAG disorders in order to collect evaluate the underlying natural history data and specimen of typical and atypical presentations of PAG disorders.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,000 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2039-12-02 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What NCT04717349 shows while recruiting
NCT04717349 is an observational study that tracks outcomes without assigning an intervention. Its 11,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 4 conditions, with Disorders of Sex Development (DSD) appearing as the primary indexed condition, and to 0 interventions.
NCT04717349 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04717349 about?
NCT04717349 is a clinical study titled "Data Collection Study of Pediatric and Adolescent Gynecology Conditions". 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...
What is the current status of trial NCT04717349?
This trial is currently recruiting. The enrollment target is 11,000 participants. The study started on 2021-04-21. Estimated completion is 2039-12-02.
What conditions does trial NCT04717349 study?
This clinical trial studies the following 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.
Who is sponsoring clinical trial NCT04717349?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04717349 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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