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NCT01294345 · ClinicalTrials.gov registry record
Personalized Genomic Research
A clinical trial, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- 353
- Enrollment target
NCT01294345: Completed study, sponsored by National Human Genome Research Institute (NHGRI).
NCT01294345 is a clinical trial that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 353 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01294345 has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- 353 participants
- Enrollment target
Study Summary
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....
Primary Outcome
genomic diagnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2011-01-24 |
| Est. Completion | 2020-09-10 |
What the finished NCT01294345 record still lists
NCT01294345 is an observational study that tracks outcomes without assigning an intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01294345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01294345 about?
NCT01294345 is a clinical study titled "Personalized Genomic Research". 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 indiv...
What is the current status of trial NCT01294345?
This trial is currently completed. The enrollment target is 353 participants. The study started on 2011-01-24. Estimated completion is 2020-09-10.
Who is sponsoring clinical trial NCT01294345?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
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