Clinical Trial: Validation of Saliva in the Esoterix Genetic Laboratories Fragile X Assay

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational

Official Title: Acquisition of Saliva Samples for Validation as a Specimen Type in the Esoterix Genetic Laboratories Fragile X Assay

Brief Summary: The purpose of this research is to determine if saliva samples can be used as an alternate sample type to test for fragile X. By using saliva instead of blood, it would be easier for patients to have fragile X testing.

Detailed Summary:

Saliva samples will be prospectively collected from subjects who have previously been tested by Esoterix Genetic Laboratories, LLC using blood specimens and diagnosed as fragile X intermediates, premutations (carriers) or full mutations (affected). Results from fragile X testing with saliva will be compared to results from the blood sample that was previously submitted to Esoterix Genetic Laboratories for testing.

Data from this study will be used for regulatory submissions.

Sponsor: Esoterix Genetic Laboratories, LLC

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Esoterix Genetic Laboratories, LLC

Dates:
Date Received: June 7, 2012
Date Started: July 2012
Date Completion: December 2012
Last Updated: June 7, 2012
Last Verified: June 2012