Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis

November 7, 2024 updated by: Shanghai Mental Health Center

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
          • Xiaoyun Guo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of neurosyphilis patients, non-neurosyphilis syphilis patients, and healthy controls aged 18-65.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of AIM2 inflammasome in peripheral blood.
Time Frame: Data will be collected at baseline, 6 months, and 12 months after enrollment.
This measure will assess the expression levels of the AIM2 inflammasome in peripheral blood samples from subjects using proteomics methods, mass spectrometry.
Data will be collected at baseline, 6 months, and 12 months after enrollment.
Measurement of NFL and sTREM2 in cerebrospinal fluid.
Time Frame: Data will be collected at baseline, 6 months, and 12 months after enrollment.
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.
Data will be collected at baseline, 6 months, and 12 months after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Cognitive Function using MoCA
Time Frame: Cognitive assessments will be conducted at baseline and 6 months post-enrollment.

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.
Cognitive assessments will be conducted at baseline and 6 months post-enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • smhcgxy_2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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