Clincosm LogoSign in Get a demo

Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05160870
Collaborator
(none)
500
Enrollment
1
Location
53.8
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aimed to find appropriate biomarkers such as serum neurofilament light chain in reflecting disease severity in hereditary ataxia from a large cohort during long-term follow-up. The disease severity is indicated by clinical scales and brain MRI tests.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia
    Actual Study Start Date :
    Jun 30, 2021
    Anticipated Primary Completion Date :
    Dec 25, 2022
    Anticipated Study Completion Date :
    Dec 25, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Serum neurofilament light chain [from 2021 to 2025]

      Serum neurofilament light chain levels were collected among patients in preclinical or mild stage of Spinocerebellar ataxia, especially type 3.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • genetically diagnosed as Spinocerebellar ataxia
    Exclusion Criteria:
    • deny follow-yp

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China 310005

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05160870
    Other Study ID Numbers:
    • Wulab-sNfL in HA
    First Posted:
    Dec 16, 2021
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ataxia
    Cerebellar Ataxia
    Spinocerebellar Degenerations

    Study Results

    No Results Posted as of Jan 12, 2022