Carpal Tunnel/Amyloidosis Blood Sample Study

Completed

• Conditions: Amyloidosis; Carpal Tunnel Syndrome

• Registration Number: NCT02587728
• Lead Sponsor: University of Miami

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Study Start: 2016-02-24
• Primary Completion: 2017-02-07
• Study Completion: 2017-02-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

• 1. Patients receiving hemodialysis
• 2. Known amyloidosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Identified with Amyloidosis	Up to 5 years	Number of carpal tunnel syndrome patients identified with amyloidosis, which will be stratified into mild, moderate or severe

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States