The Genetics of Chiari Type I Malformation

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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

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

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

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

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:

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

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