Validation of Saliva in the Esoterix Genetic Laboratories Fragile X Assay

Status unconfirmed

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01616589

Run by

Esoterix Genetic Laboratories, LLC

People needed

100

Starts

2012-07-01

Expected to finish

2012-12-01

Last updated by the study team

2012-06-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has previously been identified through molecular testing at Esoterix Genetic Laboratories as a Fragile X intermediate, premutation (carrier) or full mutation (affected).
• In the opinion of the subject's physician, the subject is medically stable and able to provide the required quantity of saliva.
• If Subject is at least 18 years of age:
• Subject must be willing to give written informed consent
• Subject must be willing to comply with the collection procedure
• If Subject is under 18 years of age, the legally authorized representative must give written informed consent and agree to comply with study procedures.

You may not qualify if…

• Subject has been determined to be an individual with a normal FMR1 gene.
• Subject has a known medical condition that would cause risk to the donor or, if relevant, the fetus as a result of saliva collection.

Where it is running

• Integrated Genetics — Westborough, Massachusetts, United States

Full record on ClinicalTrials.gov

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