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NCT02587728 Clinical Trial

Carpal Tunnel/Amyloidosis Blood Sample Study

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02587728
Other study ID # 20140503
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 24, 2016
Est. completion date February 7, 2017

Study information
Verified date August 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 7, 2017
Est. primary completion date February 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1. Patients with diagnosed carpal tunnel syndrome based on Electromyography (EMG) results. - 2. Patients with electrographic confirmation of median neuropathy at the wrist - 3. Age =18 years - 4. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: - 1. Patients receiving hemodialysis - 2. Known amyloidosis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Identified with Amyloidosis Number of carpal tunnel syndrome patients identified with amyloidosis, which will be stratified into mild, moderate or severe Up to 5 years
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