Carpal Tunnel/Amyloidosis Blood Sample Study

NCT ID: NCT02587728

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-24

Study Completion Date

2017-02-07

Brief Summary

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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

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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

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Carpal Tunnel Syndrome Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Carpal Tunnel Blood Draw

Participants with confirmed diagnosis of Carpal Tunnel Syndrome who will undergo blood draw for laboratory analysis for amyloidosis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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James Hoffman, MD

Associate Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20140503

Identifier Type: -

Identifier Source: org_study_id

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