Carpal Tunnel/Amyloidosis Blood Sample Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02587728

Enrollment

Registered

2015-10-27

Start date

2016-02-24

Completion date

2017-02-07

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis, Carpal Tunnel Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results