Status:

RECRUITING

Data Collection Study of Pediatric and Adolescent Gynecology Conditions

Lead Sponsor:

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

Conditions:

Disorders of Sex Development (DSD)

Pediatric and Adolescent Cancers of the Genital Tract

Eligibility:

All Genders

1-100 years

Brief 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 ...

Detailed Description

Study Description: The overall purpose of Pediatric and Adolescent Gynecology (PAG) evaluations under this protocol is to gather information over time from a large group of patients with PAG conditio...

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

Key Trial Info

Start Date :

April 21 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 2 2039

Estimated Enrollment :

11000 Patients enrolled

Trial Details

Trial ID

NCT04717349

Start Date

April 21 2021

End Date

December 2 2039

Last Update

April 9 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892