- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160870
Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia
December 22, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Dong
- Phone Number: + 8618367129345
- Email: dongyi720@zju.edu.cn
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310005
- Recruiting
- Second Affiliated Hospital, Zhejiang University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with Spinocerebellar ataxia
Description
Inclusion Criteria:
- genetically diagnosed as Spinocerebellar ataxia
Exclusion Criteria:
- deny follow-yp
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum neurofilament light chain
Time Frame: from 2021 to 2025
|
Serum neurofilament light chain levels were collected among patients in preclinical or mild stage of Spinocerebellar ataxia, especially type 3.
|
from 2021 to 2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2021
Primary Completion (Anticipated)
December 25, 2022
Study Completion (Anticipated)
December 25, 2025
Study Registration Dates
First Submitted
December 6, 2021
First Submitted That Met QC Criteria
December 6, 2021
First Posted (Actual)
December 16, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2022
Last Update Submitted That Met QC Criteria
December 22, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Degenerations
Other Study ID Numbers
- Wulab-sNfL in HA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sclnow Biotechnology Co., Ltd.Not yet recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6
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University of Colorado, DenverEnrolling by invitationPosterior Column Ataxia With Retinitis PigmentosaUnited States