Parkinson's Disease
Conditions
Brief summary
This observational, multicenter, non-randomized controlled study is to evaluate the detection ability of α-Synuclein Ultrafine Fluorescence Detection Method for body fluids (Such as saliva, urine, cerebrospinal fluid, and blood, etc.) and skin in Parkinson's patients.
Detailed description
Social benefits: This technology has minimal harm (skin sampling diameter of 1mm), rather than surgical traumatic brain biopsy, which meets the minimum harm and maximum benefit; 1) Clear clinical diagnosis and differential diagnosis of diseases at once, avoiding repetitive examinations, effectively saving medical expenses and medical insurance funds; 2) Beneficial for early diagnosis and intervention, reducing social and economic burden; 3) Enhance the disease diagnosis and treatment capabilities of the region, enhance basic medical research, and enhance the medical level of the region. Clinical advantage: This technology belongs to extracranial tissues α-Syn aggregate testing can replace brain biopsy procedures that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases. Clinical needs: α-Synaptic nucleoprotein lineage diseases (Parkinson's disease, multisystem atrophy, and Lewy body dementia) have complex early symptoms, making diagnosis and differential diagnosis difficult. Early diagnosis is crucial for disease prognosis. Authoritative theories suggest that brain tissue biopsy is necessary for the diagnosis of this group of diseases, but it is difficult to generalize in clinical practice. Therefore, there is a 20% misdiagnosis and missed diagnosis rate in the clinical diagnosis of α-synaptic nuclear protein spectrum diseases. The α-Synuclein Ultrafine Fluorescence Detection Method for body fluids and skin in Parkinson's patients can truly reflect the degree of pathological aggregation in synapses, which is helpful for early diagnosis and evaluation of diseases.
Interventions
DIAGNOSTIC_TESTα- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Guilin Medical College
Guangxi International Zhuang Medical Hospital
Yousheng Xiao
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with clinically defined or probable PD：According to the 2015 MDS diagnostic criteria, patients diagnosed with clinically confirmed PD regardless of age, gender, and meeting Hoehn&Yahr staging ≤ 2.5 were included as case group one, which met \[Parkinson's syndrome+at least two supportive criteria+no absolute
Exclusion criteria
\] * Patients with clinically probable PD：According to the 2015 MDS diagnostic criteria, patients diagnosed with clinically probable PD, regardless of age or gender, and meeting Hoehn&Yahr staging ≤ 2.5 were included as case group two, i.e. patients who met \[Parkinson's syndrome+no absolute
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome 2（Sensitivity and specificity） | 3 years | To define sensitivity and specificity of skin biopsy and body fluid detection of α-Synuclein Ultra Fine Fluorescence Method. |
| Primary Outcome 1（Accuracy and precision） | 3 years | To define test accuracy and precision of skin biopsy and body fluid detection of α-Synuclein Ultra Fine Fluorescence Method. |
Countries
China
Contacts
Primary ContactYousheng Xiao, professor
Outcome results
None listed