Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414746
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-16
Brief Title:
Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Observational Retrospective-prospective Study of Prevalence Clinical Characteristics of Hereditary Transthyretin Amyloidosis Polyneuropathy in Russian Patients Undergoing Surgery for CTS in Real Clinical Practice
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOCUS
Brief Summary:
This is a multicenter observational study consisting of retrospective and prospective phases The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who underwent surgery for CTS to assess their probability of having ATTR PN
Detailed Description:
ATTR PN is a genotypically phenotypically and geographically variable disease with a poor prognosis albeit available disease-modifying drugs can change the disease trajectory Thus country-specific epidemiologic data collection and identification of early stage PN including previously misdiagnosed patients is crucial to improve outcomes and quality of life However no observational studies on the epidemiology of ATTR PN in the whole Russian population or in patients with CTS have been performed
Therefore there is a need to conduct a large-scale observational study to determine the prevalence of ATTR PN in Russia obtain information on patients clinical characteristics and determine their medical needs
The approaches to diagnosis of ATTR PN in Russia over the past few years have been characterized by the use of heterogenous methods partially explained by the lack of availability of molecular genetic testing which is essential to diagnose the presence of pathogenic mutation in patients with hereditary ATTR PN Thus recent introduction of such tests into routine clinical practice may allow to assess reliable epidemiologic data including estimation of true ATTR PN prevalence among patients with CTS which can often be the first manifestation of the disease Earlier recognition in turn may lead to timely treatment initiation and change in the prognostic outlook of ATTR PN patients
In order to assess the prevalence of ATTR PN in patients undergoing surgery for CTS in Russia this study will retrospectively include patients with the diagnosis of CTS undergoing surgery between the 1st January 2021 and the 1st September 2024 Suspicion of ATTR PN will be assessed in each case and diagnostic tests comprehensive neurological examination including nerve conduction study NCS combined with molecular genetic testing to confirm or exclude the disease will be conducted prospectively in eligible patients In addition to that clinical features concomitant manifestations and diagnosed genotypes will be analyzed to examine characteristic ATTR PN patient profiles in the Russian Federation
Therefore there is a need to conduct a large-scale observational study to determine the prevalence of ATTR PN in Russia obtain information on patients clinical characteristics and determine their medical needs
The approaches to diagnosis of ATTR PN in Russia over the past few years have been characterized by the use of heterogenous methods partially explained by the lack of availability of molecular genetic testing which is essential to diagnose the presence of pathogenic mutation in patients with hereditary ATTR PN Thus recent introduction of such tests into routine clinical practice may allow to assess reliable epidemiologic data including estimation of true ATTR PN prevalence among patients with CTS which can often be the first manifestation of the disease Earlier recognition in turn may lead to timely treatment initiation and change in the prognostic outlook of ATTR PN patients
In order to assess the prevalence of ATTR PN in patients undergoing surgery for CTS in Russia this study will retrospectively include patients with the diagnosis of CTS undergoing surgery between the 1st January 2021 and the 1st September 2024 Suspicion of ATTR PN will be assessed in each case and diagnostic tests comprehensive neurological examination including nerve conduction study NCS combined with molecular genetic testing to confirm or exclude the disease will be conducted prospectively in eligible patients In addition to that clinical features concomitant manifestations and diagnosed genotypes will be analyzed to examine characteristic ATTR PN patient profiles in the Russian Federation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None