Identifying biomarkers for diagnosing neurosyphilis

Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis

This study is trying to find new ways to diagnose neurosyphilis by looking at blood samples and gut bacteria from patients to see if they can help doctors identify the condition more accurately.

Quick facts

• Study type: Observational
• Enrollment: 360 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06680011 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify diagnostic biomarkers for neurosyphilis by analyzing plasma samples and gut microbiome data from affected patients. Researchers will also evaluate electrophysiological characteristics, including EEG and eye movement, to determine their association with the condition. Participants will provide clinical information, blood and urine samples for proteomics and metagenomic sequencing, and undergo specific evaluations to gather comprehensive data. The goal is to enhance diagnostic accuracy for neurosyphilis through a multifaceted approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who meet the diagnostic criteria for neurosyphilis.

Not a fit: Patients who do not have neurosyphilis or those outside the age range of 18-65 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for neurosyphilis, facilitating earlier and more accurate treatment.

How similar studies have performed: While there have been studies on biomarkers for other conditions, this specific approach to diagnosing neurosyphilis through a combination of proteomics and electrophysiological analysis is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Neurosyphilis Patients

  1. 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).
  2. Aged 18-65 years, regardless of gender (female patients are rare in clinical practice).
  3. At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study.
  4. No contraindications for electroencephalogram (EEG) and transcranial magnetic stimulation (TMS).
* Non-neurosyphilis Syphilis Patients

  1. Positive serological tests for Treponema pallidum (e.g., Treponemal tests) and rapid plasma reagin (RPR) tests.
  2. Does not 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 and rapid plasma reagin 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).
  3. Aged 18-65 years, regardless of gender (female patients are rare in clinical practice).
  4. At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study.
  5. No contraindications for electroencephalogram (EEG).
* Healthy Controls

  1. Physically healthy (no mental illnesses or diseases affecting bodily organs).
  2. Aged 18-65 years, regardless of gender.
  3. At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study.
  4. No contraindications for electroencephalogram (EEG).

Exclusion Criteria:

* Neurosyphilis Patients \& Non-neurosyphilis Syphilis Patients

  1. Age \< 18 years or \> 65 years;
  2. Pregnant or breastfeeding women (female patients are rare in clinical practice);
  3. HIV-positive;
  4. Presence of severe primary diseases (such as liver, kidney, endocrine, or hematological diseases) accompanied by autoimmune diseases or connective tissue diseases;
  5. Presence of other central nervous system diseases besides neurosyphilis;
  6. Contraindications for transcranial magnetic stimulation (TMS) treatment, such as history of head trauma, epilepsy, or presence of metal implants;
  7. Contraindications for electroencephalography (EEG), such as severe scalp injuries, extensive or open cranial trauma, inability to place electrodes, or potential for infection from the examination.
  8. Education level below junior high school.
* Healthy Controls

  1. Age \< 18 years or \> 65 years;
  2. Pregnant or breastfeeding women;
  3. HIV-positive;
  4. Other central nervous system diseases, severe physical illnesses, or major organ diseases;
  5. Presence of severe primary diseases (such as liver, kidney, endocrine, or hematological diseases) accompanied by autoimmune diseases or connective tissue diseases;
  6. Contraindications for electroencephalography (EEG), such as severe scalp injuries, extensive or open cranial trauma, inability to place electrodes, or potential for infection from the examination;
  7. Education level below junior high school.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyun Guo, PhD

Conditions Neurosyphilis; Biomarkers; Proteomics