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Trial record 1 of 5 for:    Anencephaly
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Genetics of Spina Bifida and Anencephaly

This study is currently recruiting participants.
Verified February 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636233
First received: March 9, 2008
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • genetic factors associated with neural tube defects [ Time Frame: end of the study ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anencephaly
Fetuses with anencephaly, parents and siblings

Detailed Description:

Participation in the study is entirely voluntary.

Individuals who are currently pregnant and the pregnancy has been diagnosed with anencephaly or acrania quality to participate.

Participation involves:

  1. Completing a written consent form
  2. A phone conversation to collect family and medical information
  3. Collection of blood samples from both parents of the pregnancy
  4. Provide a fetal DNA sample (cord blood, fetal tissue or amniotic fluid)
  5. Review of medical records and ultrasound images
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Any current pregnancy affected by anencephaly or acrania.

Criteria

Any current pregnancy affected by anencephaly or acrania from which a DNA sample can be collected.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636233

Contacts
Contact: Heidi Cope, MS, CGC 919-684-0655 heidi.cope@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Heidi Cope, MS, CGC     919-684-0655     heidi.cope@duke.edu    
Principal Investigator: Allison Ashley-Koch, PhD            
Sub-Investigator: Simon Gregory, PhD            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Allison Ashley-Koch, PhD Duke University Health System
  More Information

Additional Information:
Anencephaly study description  This link exits the ClinicalTrials.gov site
Neural tube defect study description  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636233     History of Changes
Other Study ID Numbers: Pro00016517, R01 NS039818
Study First Received: March 9, 2008
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013