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NCT Number: NCT02587728

Carpal Tunnel/Amyloidosis Blood Sample Study

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.

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Key information

Conditions

Carpal Tunnel Syndrome Amyloidosis Cumulative Trauma Disorders Median Neuropathy Metabolic Diseases Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants Identified with Amyloidosis

    Time frame: Up to 5 years

    Number of carpal tunnel syndrome patients identified with amyloidosis, which will be stratified into mild, moderate or severe

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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