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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 : March 28, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date March 9, 2008
First Posted Date March 14, 2008
Last Update Posted Date March 28, 2019
Study Start Date May 1993
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00636233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetics of Spina Bifida and Anencephaly
Official Title The Hereditary Basis of Neural Tube Defects
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, saliva, cord blood, fetal tissue, cultured fetal cells
Sampling Method Probability Sample
Study Population Any current pregnancy affected by anencephaly or acrania.
Condition
  • Anencephaly
  • Acrania
Intervention Not Provided
Study Groups/Cohorts Anencephaly
Fetuses with anencephaly, parents and siblings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 9, 2008)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria Not currently enrolling new participants.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00636233
Other Study ID Numbers Pro00016517
R01NS039818 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Allison Ashley-Koch, PhD Duke University Health System
PRS Account Duke University
Verification Date March 2019