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Genetics of Spina Bifida and Anencephaly

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ClinicalTrials.gov Identifier: NCT00636233
Recruitment Status : Active, not recruiting
First Posted : March 14, 2008
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University

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 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 2025
Estimated Study Completion Date : May 2025


Group/Cohort
Anencephaly
Fetuses with anencephaly, parents and siblings



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


Information from the National Library of Medicine

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

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


Locations
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)
Investigators
Principal Investigator: Allison Ashley-Koch, PhD Duke University Health System

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: April 18, 2018
Last Verified: April 2018
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:
anencephaly
acrania

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