Clinical Trial: Carpal Tunnel/Amyloidosis Blood Sample Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Collection of Peripheral Blood Samples From Patients With Carpal Tunnel Syndrome for Laboratory Screening of Amyloidosis

Brief Summary: Carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients. This specimen collection protocol will allow the investigators to screen patients with carpal tunnel syndrome for amyloidosis.

Detailed Summary: The investigators propose to assess a high risk population of patients, those with carpal tunnel syndrome, and systematically assess them for Amyloid Light-chain (AL) amyloidosis and Transthyretin-Related Amyloidosis (ATTR) with simple laboratory blood tests. The combination of serum immunofixation electrophoresis together with serum free light chain (FLC) assay approaches 100% sensitivity for identifying the monoclonal protein underlying the illness in patients with AL amyloidosis. In addition to this, testing for transthyretin gene mutations will allow the investigators to identify patients with ATTR. The investigators believe this simple screening panel (serum immunofixation and serum FLC assay and transthyretin mutation analysis) may allow the investigators to identify patients early in the course of their disease, at which point the investigators can intervene with effective treatment and spare patients a significant amount of morbidity and mortality.
Sponsor: University of Miami

Current Primary Outcome: Number of Participants Identified with Amyloidosis [ Time Frame: Up to 5 years ]

Number of carpal tunnel syndrome patients identified with amyloidosis, which will be stratified into mild, moderate or severe


Original Primary Outcome: Number of Participants Identified with Amyloidosis [ Time Frame: Up to 5 years ]

Number of carpal tunnel syndrome patients identified with amyloidosis.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Miami

Dates:
Date Received: October 23, 2015
Date Started: February 24, 2016
Date Completion: November 2020
Last Updated: March 31, 2017
Last Verified: March 2017