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Genetics of Spina Bifida and Anencephaly

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636233
First received: March 9, 2008
Last updated: June 16, 2017
Last verified: April 2017
  Purpose
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
Anencephaly Acrania

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: The Hereditary Basis of Neural Tube Defects

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 10000
Study Start Date: May 1993
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anencephaly
Fetuses with anencephaly, parents and siblings

  Eligibility

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.
Criteria
Not currently enrolling new participants.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636233     History of Changes
Other Study ID Numbers: Pro00016517
R01NS039818 ( US NIH Grant/Contract Award Number )
Study First Received: March 9, 2008
Last Updated: June 16, 2017
Individual Participant Data  
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:
Neural Tube Defects
Anencephaly
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Abnormalities, Severe Teratoid

ClinicalTrials.gov processed this record on June 22, 2017