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A Multicenter Cohort Study Evaluating Skin and Fluid Biopsies for Early and Precise Diagnosis of Synucleinopathies

A Multicenter Cohort Study Evaluating Skin and Fluid Biopsies for Early and Precise Diagnosis of Synucleinopathies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114653
Enrollment
Unknown
Registered
2025-12-16
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Synucleinopathy

Interventions

Gold Standard:2015 MDS Parkinson's Disease Diagnostic Criteria, 2022 MDS MSA Diagnostic Criteria, 2017 4th Edition DLB Diagnostic Criteria, Polysomnography Monitoring, etc
Index test:Plasma cell-free RNA (cfRNA), skin phosphorylation a-synuclein deposition, cutaneous a-synuclein seeding activity.

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: Clinical Cohort of Synucleinopathies Inclusion criteria: Ages 40-75, diagnosed with probable PD according to the 2015 MDS criteria, probable MSA according to the 2022 MDS criteria, probable DLB according to the 2017 fourth edition clinical criteria, and non-synucleinopathy patients. All subjects must provide written informed consent. Early Risk Population Cohort for Synucleinopathies Inclusion criteria: Ages 30-75, patients diagnosed with idiopathic REM sleep behavior disorder (iRBD) through polysomnography, PAF patients meeting the autonomic failure criteria for probable MSA according to the 2022 MDS criteria, and healthy volunteers. All subjects must provide written informed consent.

Exclusion criteria

Exclusion criteria: ? Clinical cohort of synucleinopathies Exclusion criteria: Patients with other serious neurological diseases, significant cognitive impairment, or systemic diseases that may affect the study results. ? Early risk population cohort for synucleinopathies Exclusion criteria: Patients with other serious neurological diseases, significant cognitive impairment, or systemic diseases that may affect the study results.

Design outcomes

Primary

MeasureTime frame
cell-free RNA ;Sensitivity;Specificity;

Secondary

MeasureTime frame
Skin phosphorylation a-synuclein pathology;Skin a-synuclein seeding activity;

Countries

China

Contacts

Public ContactJing Yang

The First Affiliated Hospital of Zhengzhou University

yangjing9527@126.com+86 136 3383 5271

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026