NCT05160870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

January 12, 2022

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

December 6, 2021

Last Update Submit

December 22, 2021

Conditions

Hereditary Ataxia

Outcome Measures

Primary Outcomes (1)

  • Serum neurofilament light chain

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

    from 2021 to 2025

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with Spinocerebellar ataxia

You may qualify if:

  • genetically diagnosed as Spinocerebellar ataxia

You may not qualify if:

  • deny follow-yp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310005, China

RECRUITING

MeSH Terms

Conditions

Spinocerebellar Degenerations

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yi Dong

CONTACT

+ 8618367129345dongyi720@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 16, 2021

Study Start

June 30, 2021

Primary Completion

December 25, 2022

Study Completion

December 25, 2025

Last Updated

January 12, 2022

Record last verified: 2021-11

Locations

CN(1)