NCT02587728

Carpal Tunnel/Amyloidosis Blood Sample Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Carpal Tunnel Syndrome
• Amyloidosis

Timeline

• Start date: 2016-02-24
• Primary completion: 2017-02-07
• Completion: 2017-02-07
• First posted: 2015-10-27
• Last updated: 2021-08-26

Locations

1 site across 1 country: United States