NCT02587728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 24, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2017

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

October 23, 2015

Last Update Submit

August 20, 2021

Conditions

Carpal Tunnel SyndromeAmyloidosis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Identified with Amyloidosis

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

    Up to 5 years

Study Arms (1)

Carpal Tunnel Blood Draw

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients within 24 months of confirmed diagnosis of Carpal Tunnel Syndrome

You may qualify if:

  • \. Patients with diagnosed carpal tunnel syndrome based on Electromyography (EMG) results.
  • \. Patients with electrographic confirmation of median neuropathy at the wrist
  • \. Age ≥18 years
  • \. Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

  • \. Patients receiving hemodialysis
  • \. Known amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genome DNA extracted peripheral blood mononuclear cells (PBMCs)

MeSH Terms

Conditions

Carpal Tunnel SyndromeAmyloidosis

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • James Hoffman, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

February 24, 2016

Primary Completion

February 7, 2017

Study Completion

February 7, 2017

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)