Trial record 13 of 20 for:    Open Studies | "Neural Tube Defects"

The Genetics of Chiari Type I Malformation

This study is currently recruiting participants.
Verified March 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01060800
First received: February 1, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

Duke University Medical Center is investigating the hereditary basis of Chiari type I malformations with or without syringomyelia (CM1/S). Our research is aimed at learning if CM1/S is indeed caused by factors inherited through the family and, if so, which genes are involved.


Condition
Chiari Type I Malformation

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: The Genetics of Chiari Type I Malformation (CMI) With or Without Syringomyelia

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Genetic factors contributing to Chiari Type I malformation [ Time Frame: end of study ] [ Designated as safety issue: No ]
    This study aims to identify genetic factors that contribute to or cause Chiari Type I malformation.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, DNA


Estimated Enrollment: 2000
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Duke University Medical Center is actively recruiting families who have TWO OR MORE family members with Chiari Type I Malformations, with or without syringomyelia. These family members must be related to each other by blood, and BOTH must be willing to participate.

  Eligibility

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

Families who have TWO OR MORE family members with Chiari Type I Malformation, with or without syringomyelia. These family members must be related to each other by blood, and BOTH must be willing to participate.

Criteria

Inclusion Criteria:

  • Families who have TWO OR MORE family members with Chiari Type I Malformation, with or without syringomyelia. These family members must be related to each other by blood, and BOTH must be willing to participate.

Exclusion Criteria:

  • Singleton cases of Chiari Type I Malformation
  • Presence of supratentorial or infratentorial tumors
  • Presence of a lumbar shunt
  • History of birth trauma
  • History of spina bifida
  • History of cervical or cranial surgery unrelated to CM1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060800

Contacts
Contact: Heidi Cope, MS, CGC 877-825-1694 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    877-825-1694    chiari@chg.duhs.duke.edu   
Principal Investigator: Allison Ashley-Koch, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Allison Ashley-Koch, PhD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01060800     History of Changes
Other Study ID Numbers: Pro00011231
Study First Received: February 1, 2010
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Chiari
Chiari Type I
Chiari Type I Malformation
Familial Chiari

Additional relevant MeSH terms:
Congenital Abnormalities
Arnold-Chiari Malformation
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014