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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02587728
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
James Hoffman, MD, University of Miami

Study Description
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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
Carpal Tunnel Syndrome 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.
Study Design
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Study Type : Observational
Actual Enrollment : 10 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
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Carpal Tunnel Blood Draw
Participants with confirmed diagnosis of Carpal Tunnel Syndrome who will undergo blood draw for laboratory analysis for amyloidosis.


Outcome Measures
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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)

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02587728


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: James Hoffman, MD University of Miami
More Information
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Responsible Party: James Hoffman, MD, Associate Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT02587728    
Other Study ID Numbers: 20140503
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Amyloidosis
Syndrome
Disease
Pathologic Processes
Proteostasis Deficiencies
Metabolic Diseases
Median Neuropathy
 Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries