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Trial record 1 of 6 for:    "anencephaly"
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Genetics of Spina Bifida and Anencephaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00636233
Recruitment Status : Active, not recruiting
First Posted : March 14, 2008
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.

Condition or disease
Anencephaly Acrania

Study Design

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: The Hereditary Basis of Neural Tube Defects
Study Start Date : May 1993
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Groups and Cohorts

Fetuses with anencephaly, parents and siblings

Outcome Measures

Primary Outcome Measures :
  1. genetic factors associated with neural tube defects [ Time Frame: end of the study ]
    This study aims to discover genetic factors associated with neural tube defects such as anencephaly.

Biospecimen Retention:   Samples With DNA
Whole blood, serum, saliva, cord blood, fetal tissue, cultured fetal cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any current pregnancy affected by anencephaly or acrania.
Not currently enrolling new participants.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636233

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Allison Ashley-Koch, PhD Duke University Health System
More Information

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636233     History of Changes
Other Study ID Numbers: Pro00016517
R01NS039818 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

Additional relevant MeSH terms:
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Abnormalities, Severe Teratoid
Congenital Abnormalities