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The Genetics of Chiari Type I Malformation

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: NCT01060800
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date February 1, 2010
First Posted Date February 2, 2010
Last Update Posted Date April 2, 2020
Study Start Date June 2009
Actual Primary Completion Date April 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2013)
Genetic factors contributing to Chiari Type I malformation [ Time Frame: end of study ]
This study aims to identify genetic factors that contribute to or cause Chiari Type I malformation.
Original Primary Outcome Measures Not Provided
Change History
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 The Genetics of Chiari Type I Malformation
Official Title The Genetics of Chiari Type I Malformation (CMI) With or Without Syringomyelia
Brief Summary 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.
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, DNA
Sampling Method Non-Probability Sample
Study Population The study is not currently enrolling new participants.
Condition Chiari Type I Malformation
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Estimated Enrollment
 (submitted: February 1, 2010)
2000
Original Estimated Enrollment Same as current
Actual Study Completion Date April 25, 2017
Actual Primary Completion Date April 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria The study is 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 NCT01060800
Other Study ID Numbers Pro00011231
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
Current Responsible Party Duke University
Original Responsible Party Allison Ashley-Koch, PhD, Duke University Medical Center
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Allison Ashley-Koch, PhD Duke University
PRS Account Duke University
Verification Date March 2019