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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00636233 |
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 |
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Anencephaly Spina Bifida Neural Tube Defect |
Study Type: | Observational |
Study Design: | Family-Based, Cross-Sectional |
Official Title: | The Hereditary Basis of Neural Tube Defects |
Whole blood, serum, saliva, cord blood, fetal tissue, cultured fetal cells
Estimated Enrollment: | 10000 |
Study Start Date: | May 1993 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Spina Bifida
Individuals with spina bifida and their family members
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Anencephaly
Fetuses with anencephaly, parents and siblings
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Neural Tube Defect
Individuals with neural tube defects other than spina bifida and anencephaly and their family members
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Participation in the study is entirely voluntary. Any family with at least one family member with a neural tube defect is eligible to participate.
Participation involves:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Any individual with a neural tube defect and their family members. Any current pregnancy affected by anencephaly.
Inclusion Criteria:
Exclusion Criteria:
Contact: Heidi Cope, MS | 1-866-385-3683 | heidi.cope@duke.edu |
Contact: Debbie Siegel, BS | 1-866-385-3683 | dsiegel@chg.duhs.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Heidi Cope, MS 866-385-3683 heidi.cope@duke.edu | |
Contact: Debbie Siegel, BS 1-866-385-3683 siege004@chg.duhs.duke.edu | |
Principal Investigator: Allison Ashley-Koch, PhD | |
Sub-Investigator: Simon Gregory, PhD |
Principal Investigator: | Allison Ashley-Koch, PhD | Duke University Health System |
Responsible Party: | Duke University Health Sysem ( Drs. Allison Ashley-Koch and Simon Gregory ) |
Study ID Numbers: | 0870-07-5R16, R01 NS039818 |
Study First Received: | March 9, 2008 |
Last Updated: | March 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00636233 |
Health Authority: | United States: Institutional Review Board |
anencephaly spina bifida neural tube defects encephalocele |
Neural Tube Defects Nervous System Malformations Spinal Dysraphism Spina bifida |
Neural tube defect, folate-sensitive Congenital Abnormalities Anencephaly |
Nervous System Diseases Monsters |