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Carpal Tunnel/Amyloidosis Blood Sample Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02587728
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : May 22, 2020
Information provided by (Responsible Party):
James Hoffman, MD, 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.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Amyloidosis Procedure: Blood Draw

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Peripheral Blood Samples From Patients With Carpal Tunnel Syndrome for Laboratory Screening of Amyloidosis
Actual Study Start Date : February 24, 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
Carpal Tunnel Blood Draw
Participants with confirmed diagnosis of Carpal Tunnel Syndrome who will undergo blood draw for laboratory analysis for amyloidosis.
Procedure: Blood Draw
Samples to be obtained from all subjects will include at least 30 cc of whole blood. Blood specimens will be obtained specifically for the purposes of this study, and will be collected at intervals required for clinical purposes to minimize the need for additional blood draws of study participants.
Other Name: Venipuncture

Primary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Genome DNA extracted peripheral blood mononuclear cells (PBMCs)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients within 24 months of confirmed diagnosis of Carpal Tunnel Syndrome

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02587728

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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: James Hoffman, MD    305-243-4860   
The Ouellette Group Physicians For The Hand Recruiting
Miami, Florida, United States, 33146
Contact: Elizabeth Anne Ouellette, MD, MBA    786-457-6706   
Sponsors and Collaborators
University of Miami
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Principal Investigator: James Hoffman, MD University of Miami
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Responsible Party: James Hoffman, MD, Associate Professor of Clinical, University of Miami Identifier: NCT02587728    
Other Study ID Numbers: 20140503
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Hoffman, MD, University of Miami:
Carpal Tunnel Syndrome
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries