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Completed No phase listed Observational Accepts healthy volunteers

Personalized Genomic Research

ClinicalTrials.gov ID: NCT01294345

Public ClinicalTrials.gov record NCT01294345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 12:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Background: \- Congenital malformations, sometimes called birth defects, occur because of a difference in early human development. There are many different types of congenital malformations, and some of these can be caused by changes in genetic material. Researchers are interested in studying individuals with these congenital malformations to better understand the causes and the effects of certain congenital malformations. Objectives: * To understand more about what causes congenital malformations that arise in early human development. * To learn if genetic causes can be found to explain why a person has a congenital malformation. Eligibility: \- Individuals who have been diagnosed with a congenital malformation. Design: * Participants will be seen at the National Institutes of Health for a series of visits over 3 to 4 days. Participants will be asked to provide copies of past medical records and test results for review, and will be asked questions about pregnancy/prenatal history, birth, newborn, medical, developmental, and family history. * Parents or siblings of participants may also be asked to provide information for research purposes. * Participants may have additional medical evaluations as part of this study, including any of the following tests: * Physical examinations * Other consultations as clinically indicated * Blood samples for genetic testing * Tissue biopsy for genetic testing * Photographs of affected areas, such as front and side views of the face and other body parts that may be involved in a congenital malformation, like the hands and feet. * Other tests as indicated by a specific malformation, such as organ ultrasounds. * No additional invasive testing, testing requiring sedation, or testing involving radiation is planned for this protocol. These tests, if performed, would involve a separate consent....

Study identification

NCT ID
NCT01294345
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
353 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Month and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 23, 2011
Primary completion
Jul 31, 2020
Completion
Sep 9, 2020
Last update posted
Sep 13, 2020

2011 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01294345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 13, 2020 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01294345 live on ClinicalTrials.gov.

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