Collecting data on gynecologic conditions in children and adolescents

Data Collection Study of Pediatric and Adolescent Gynecology Conditions

This study is collecting information from children and teens with gynecologic conditions to better understand these issues and improve future care.

Quick facts

• Study type: Observational
• Enrollment: 11000 (estimated)
• Ages: 1 Day to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT04717349 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather comprehensive data over time from a diverse group of young individuals with known or suspected pediatric and adolescent gynecologic conditions. Participants will undergo medical record reviews, physical exams, and genetic testing through blood and saliva samples. The goal is to create a large database that captures the variety and presentation of these conditions to enhance understanding and improve future care.

Who should consider this trial

Good fit: Ideal candidates include children and adolescents with known or suspected gynecologic conditions, as well as their adult family members.

Not a fit: Patients without any known or suspected pediatric and adolescent gynecologic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for pediatric and adolescent gynecologic conditions.

How similar studies have performed: While this approach is focused on data collection, similar studies have shown success in enhancing understanding of pediatric conditions through comprehensive databases.

Eligibility criteria

* INCLUSION CRITERIA FOR PAG PATIENTS:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Participants with known or suspected pediatric and adolescent gynecologic conditions of any age are eligible for this protocol.

INCLUSION CRITERIA FOR PAG PATIENTS OF FAMILY MEMBERS:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. 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.

EXCLUSION CRITERIA:

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

1. 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.
2. Pregnant family members

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Veronica Gomez-Lobo, M.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Study coordinator: Veronica Gomez-Lobo, M.D.

Conditions: Disorders of Sex Development, Pediatric and Adolescent Cancers of the Genital Tract, Reproductive Endocrine Conditions in Puberty, Structural Gynecologic Conditions Including Vulvar and Vaginal Conditions, Congenital Anomalies, Disorders of sex development, Childhood and adolescence cancers, Adolescent fertility