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Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP) (AMYLYONCARP)

Primary Purpose

Carpal Tunnel Syndrome Bilateral

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tenosynovial tissue biopsy
Sponsored by
Centre Hospitalier Saint Joseph Saint Luc de Lyon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carpal Tunnel Syndrome Bilateral

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • bilateral carpal tunnel with indication of surgery and judged suspect:
  • age of 50 years old and more
  • non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy

Exclusion Criteria:

  • patient with diagnosis of amyloidosis
  • traumatic bilateral carpal tunnel or linked to rheumatoid arthritis

Sites / Locations

  • Centre Hospitalier Saint Joseph Saint LucRecruiting

Outcomes

Primary Outcome Measures

Prevalence of amyloid aggregate
Research of amyloid aggregate in tenosynovial tissue

Secondary Outcome Measures

Typing of amyloid aggregate
Caracterization of amyloid aggregate in tenosynovial tissue

Full Information

First Posted
May 6, 2021
Last Updated
May 15, 2023
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04890119
Brief Title
Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)
Acronym
AMYLYONCARP
Official Title
Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome Bilateral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
tenosynovial tissue biopsy
Intervention Description
Biopsy of tenosynovial tissue during surgery for amyloid aggregate search
Primary Outcome Measure Information:
Title
Prevalence of amyloid aggregate
Description
Research of amyloid aggregate in tenosynovial tissue
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Typing of amyloid aggregate
Description
Caracterization of amyloid aggregate in tenosynovial tissue
Time Frame
During surgery
Other Pre-specified Outcome Measures:
Title
Research of organ amyloidosis (context of standard care): exploratory
Description
Among positive patients, additional exams will be performed in the context of standard care in order to research for organ amyloidosis: blood sampling, EKG, echocardiography and other organ exams according to type of amyloidosis
Time Frame
in the 3 months following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bilateral carpal tunnel with indication of surgery and judged suspect: age of 50 years old and more non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy Exclusion Criteria: patient with diagnosis of amyloidosis traumatic bilateral carpal tunnel or linked to rheumatoid arthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe SCHIELE, MD
Phone
478 618 216
Ext
+33
Email
pschiele@chsjsl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa GREEN, MD
Phone
478 618 602
Ext
+33
Email
lgreen@chsjsl.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe SCHIELE, MD
Organizational Affiliation
Centre Hospitalier Saint Joseph Saint Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Rio
Email
srio@chsjsl.fr
First Name & Middle Initial & Last Name & Degree
Philippe SCHIELE, MD
First Name & Middle Initial & Last Name & Degree
Camille BARANI, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

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