Prevalence Study of Amyloidosis in Patients With Surgery... | NCT04890119

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

NCT04890119

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status

Unknown status

Last Update Posted

May 16, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Carpal Tunnel Syndrome Bilateral

Interventions

tenosynovial tissue biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2021Actual

Primary Completion Date

Jun 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

May 6, 2021

First Submission Date that Met QC Criteria

May 17, 2021

First Posted Date

May 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2023

Last Update Posted Date

May 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tenosynovial tissue biopsy	Diagnostic Test	Biopsy of tenosynovial tissue during surgery for amyloid aggregate search

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of amyloid aggregate	Research of amyloid aggregate in tenosynovial tissue	During surgery

Secondary Outcomes

Measure	Description	Time Frame
Typing of amyloid aggregate	Caracterization of amyloid aggregate in tenosynovial tissue	During surgery

Other Outcomes

Measure	Description	Time Frame
Research of organ amyloidosis (context of standard care): exploratory	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	in the 3 months following surgery

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Philippe SCHIELE, MD	Contact	478 618 216	+33	pschiele@chsjsl.fr
Lisa GREEN, MD	Contact	478 618 602	+33	lgreen@chsjsl.fr

Overall Officials

Name	Affiliation	Role
Philippe SCHIELE, MD	Centre Hospitalier Saint Joseph Saint Luc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Saint Joseph Saint Luc	Recruiting	Lyon		69007	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided