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Protocol Details

Data Collection Study of Pediatric and Adolescent Gynecology Conditions

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-CH-0126

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Congenital Anomalies;
Disorders of sex development (DSD);
Childhood and adolescence cancers;
Adolescent fertility;
Natural History

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Veronica Gomez-Lobo, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CLINICAL CENTER BG RM 8N248B
10 CENTER DR
BETHESDA MD 20892
(301) 435-7567
veronica.gomez-lobo@nih.gov

Veronica Gomez-Lobo, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CLINICAL CENTER BG RM 8N248B
10 CENTER DR
BETHESDA MD 20892
(301) 435-7567
veronica.gomez-lobo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04717349

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