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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
360 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov