Neuropathic Pain Clinical Trial
— TRAP2-1Official title:
Screening for the Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP): An International, Multicenter, Epidemiological Protocol
NCT number | NCT01705626 |
Other study ID # | TRAP 08-2012 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | May 27, 2022 |
Verified date | May 2022 |
Source | CENTOGENE GmbH Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
An International, multicenter, epidemiological observational study investigating the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in participants with small fiber polyneuropathy of no obvious etiology.
Status | Completed |
Enrollment | 500 |
Est. completion date | May 27, 2022 |
Est. primary completion date | May 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Informed consent is obtained from the participant - The participant is aged between 18 and 85 years of age - The participant is diagnosed with small fiber polyneuropathy of no obvious etiology - The participant has no diagnosis of alcoholism, according to International Guidelines - The participant has not undergone chemotherapy for carcinoma Exclusion Criteria: - Inability to provide informed consent - The participant is younger than 18 years or older than 85 years of age - The etiology of the small fiber polyneuropathy is clearly determined - The participant has a diagnosis of alcoholism, according to International Guidelines - The participant has undergone chemotherapy for carcinoma |
Country | Name | City | State |
---|---|---|---|
Austria | Klinikum Wels-Grieskirchen GmbH, Abteilung für Neurologie | Wels | |
Hungary | University of Pécs, Department of Neurology | Pécs | |
Hungary | University of Szeged, Department of Neurology | Szeged | |
North Macedonia | University Hospital Skopje, Department of Neurology | Skopje | |
Poland | Jagiellonian University Medical College, Department of Neurology | Kraków | |
Serbia | Clinical Hospital Center Zvezdara, Department of Neurology | Belgrad | |
Serbia | University of Belgrade, Clinical Center of Serbia, Neurology Clinic, Neuropathy Center | Belgrade | |
Serbia | Clinical Center Niš, Department of Neurology | Niš | |
Serbia | General Hospital "Dr. Djordje Joanovic" | Zrenjanin | |
Spain | Hospital Infanta Leonor | Madrid | |
Spain | Hospital Universitario Donostia | San Sebastián |
Lead Sponsor | Collaborator |
---|---|
CENTOGENE GmbH Rostock |
Austria, Hungary, North Macedonia, Poland, Serbia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epidemiological analysis of prevalence of the TTR FAP in participants with small fiber polyneuropathy of no obvious etiology. | Dry Blood Spot (DBS) samples will be genetically validated via combination of Next-Generation Sequencing (the mutation will be confirmed by Sanger sequencing) and the Multiplex ligation-dependent probe amplification (MLPA) of TTR gene | 3 years | |
Secondary | Establishment of a biomarker in TTR-positive cohort | Samples carrying a mutation in the TTR gene will be biochemically analyzed via liquid chromatography multiple reaction monitoring MS and compared with a merged control cohort, in order to establish TTR mutation-specific biomarker/s. | 3 years |
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