Development of a screening tool for hATTR polyneuropathy (AmyloScan®)

Recruiting

• Conditions: E85.1; G63; M17; Neuropathic heredofamilial amyloidosis; Polyneuropathy in diseases classified elsewhere; Gonarthrosis [arthrosis of knee]

• Registration Number: DRKS00021577
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Study participants have to suffer from one of the following disease entities:
- ATTRv amlyoidosis with polyneuropathy (documented mutation)
- polyneuropathy of other etiology
- pain caused by knee osteoarthritis

Study participants must have signed a consent form in which they declare that they understand the purpose of the study and the procedures used in it and that they consent to the study. Participants must be able to communicate adequately and be able to identify and differentiate the location and intensity of pain and complete the questionnaires used in this study.

Exclusion Criteria

Exclusion criteria are pain syndromes of other causes, which could possibly compete with the pain, and severe psychiatric disorders, e.g. severe depression.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study is to develop a simple screening tool (history questions and potentially a short sensory testing procedure) to detect ATTRv amyloidosis with polyneuropathy early in the disease course and to distinguish it from other painful neuropathies or diseases with pain in the extremities. For this purpose, cut-off scores with the best discriminative value for ATTRv amyloidosis will be identified by examining the patients with different questionnaires and testing procedures.

Secondary Outcome Measures

Name	Time	Method
See Primary Outcome