Data Collection Study of Pediatric and Adolescent Gynecology Conditions
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|ClinicalTrials.gov Identifier: NCT04717349|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : September 30, 2022
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.
To create a database about child and teenage gynecologic conditions.
Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members
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.
|Condition or disease|
|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|
The overall purpose of PAG evaluations under this protocol is to gather information over time from a large group of patients with PAG conditions to help improve our understanding of these conditions. Our aim is to create a large database of PAG conditions in presentation and variety.
- Recruit a diverse population of pediatric and adult subjects with known or suspected PAG disorders in order to collect data and specimen of typical and atypical presentations of PAG disorders.
- Create a large database of PAG conditions in presentation and variety.
|Study Type :||Observational|
|Estimated Enrollment :||11000 participants|
|Official Title:||Data Collection Study of Pediatric and Adolescent Gynecology Conditions|
|Actual Study Start Date :||April 21, 2021|
|Estimated Primary Completion Date :||December 2, 2039|
|Estimated Study Completion Date :||December 2, 2039|
Family Members of PAG patients
Clinical evaluation of family members that would provide clinical information related to the diagnosis of a proband in future research.
Pediatric and adolescent patients with gynecologic conditions.
- Recruit a diverse population of pediatric and adult subjects [ Time Frame: Ongoing ]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.
- Create a large database of PAG conditions [ Time Frame: Ongoing ]Create a large database of PAG conditions in presentation and variety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717349
|Contact: Veronica Gomez-Lobo, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Veronica Gomez-Lobo, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|