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

  • INCLUSION CRITERIA FOR PAG PATIENTS:
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 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:
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 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:
  • 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.
  • Pregnant family members

Exclusion

    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

    September 12 2025

    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