Data Collection Study of Pediatric and Adolescent Gynecology Conditions

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

Eligibility Criteria

Sex

ALL

Age

1 Day - 100 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Apr 21, 2021

Status verified

Apr 2026

Primary completion

Dec 2, 2039

Completion

Dec 2, 2039

Study Design

Enrollment

11,000 participants (estimated)

Arms

• Arm: 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.
• Arm: PAG patient
  Pediatric and adolescent patients with gynecologic conditions.

Primary Outcome Measure

Recruit a diverse population of pediatric and adult subjects [ Time Frame: Ongoing ]

Central Contacts

• Veronica Gomez-Lobo, M.D.
  (301) 435-7567
  [email protected]

Locations (1)

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