Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShanghai Mental Health Center
About this trial
The goal of this observational study is to identify diagnostic biomarkers for neurosyphilis in patients with the condition. The main questions it aims to answer are:
What plasma biomarkers are associated with neurosyphilis? What electrophysiological characteristics (EEG and eye movement) are linked to neurosyphilis? Researchers will compare biomarker data from plasma and gut microbiome analyses with electrophysiological findings to see if these factors can help diagnose neurosyphilis.
Participants will:
Provide clinical information such as age, gender, symptoms, and disease course Submit blood and urine samples for proteomics and metagenomic sequencing Undergo EEG and eye movement evaluations for electrophysiological analysis
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Neurosyphilis Patients
Meet the diagnostic criteria for neurosyphilis in this study based on the 2015 Sexually Transmitted Diseases Treatment Guidelines published by the Centers for Disease Control and Prevention (CDC) and the 2020 European Guideline on the Management of Syphilis: ① Positive serological tests for Treponema pallidum (e.g., Treponemal tests) and rapid plasma reagin (RPR) tests; ② Positive cerebrospinal fluid tests for Treponema pallidum particle agglutination assay (TPPA), the toluidine red unheated serum test (TRUST), and the Venereal Disease Research Laboratory test (VDRL).
Aged 18-65 years, regardless of gender (female patients are rare in clinical practice).
At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study.
Disqualifiers
Neurosyphilis Patients & Non-neurosyphilis Syphilis Patients
Age < 18 years or > 65 years;
Pregnant or breastfeeding women (female patients are rare in clinical practice);
HIV-positive;
Trial population
The study population consists of neurosyphilis patients, non-neurosyphilis syphilis patients, and healthy controls aged 18-65.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
360 Participants
are grouped into 3 trial groupsGroup A: Neurosyphilis Patients
Group B: Non-neurosyphilis Syphilis Patients
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
Measurement of AIM2 inflammasome in peripheral blood.
This measure will assess the expression levels of the AIM2 inflammasome in peripheral blood samples from subjects using proteomics methods, mass spectrometry.
Time frame
Data will be collected at baseline, 6 months, and 12 months after enrollment.2
Measurement of NFL and sTREM2 in cerebrospinal fluid.
This measure will evaluate the levels of neurofilament light chain (NFL) and myeloid cells 2 (sTREM2) in cerebrospinal fluid samples from subjects. The measurement will utilize techniques such as TRUST, TPPA and mass spectrometry to assess these biomarkers.
Time frame
Data will be collected at baseline, 6 months, and 12 months after enrollment.Secondary outcomes
1
Assessment of Cognitive Function using MoCA
This measure will evaluate cognitive function in subjects using the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point test that assesses multiple cognitive domains, including visuospatial and executive functions, naming, memory, attention, language, and orientation. Higher scores indicate better cognitive function, with a maximum possible score of 30. A score of 26 or above is considered within the normal range, while a score of 25 or below may indicate mild cognitive impairment.
Time frame
Cognitive assessments will be conducted at baseline and 6 months post-enrollment.Sponsors and contacts
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Source ClinicalTrials.gov