NeurosyphilisNCT06680011
Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis
An observational study of Neurosyphilis and Biomarkers, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurosyphilis, Biomarkers, Proteomics
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of neurosyphilis patients, non-neurosyphilis syphilis patients, and healthy controls aged 18-65.
Who may be able to join
- 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.
- No contraindications for electroencephalogram (EEG) and transcranial magnetic stimulation (TMS).
- Non-neurosyphilis Syphilis Patients
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- Positive serological tests for Treponema pallidum (e.g., Treponemal tests) and rapid plasma reagin (RPR) tests.
- 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).
- 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.
- No contraindications for electroencephalogram (EEG).
- Healthy Controls
- Physically healthy (no mental illnesses or diseases affecting bodily organs).
- Aged 18-65 years, regardless of gender.
- At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study.
- No contraindications for electroencephalogram (EEG).
Who cannot join
- 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;
- Presence of severe primary diseases (such as liver, kidney, endocrine, or hematological diseases) accompanied by autoimmune diseases or connective tissue diseases;
- Presence of other central nervous system diseases besides neurosyphilis;
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- Contraindications for transcranial magnetic stimulation (TMS) treatment, such as history of head trauma, epilepsy, or presence of metal implants;
- 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.
- Education level below junior high school.
- Healthy Controls
- Age < 18 years or > 65 years;
- Pregnant or breastfeeding women;
- HIV-positive;
- Other central nervous system diseases, severe physical illnesses, or major organ diseases;
- Presence of severe primary diseases (such as liver, kidney, endocrine, or hematological diseases) accompanied by autoimmune diseases or connective tissue diseases;
- 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;
- Education level below junior high school.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Xiaoyun Guo, PhD
About this study
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.
Read more
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
- Conditions
- Neurosyphilis, Biomarkers, Proteomics
- Medical subject headings
- Neurosyphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be collected at baseline, 6 months, and 12 months after enrollment.
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.
Measured: 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.
Measured: Cognitive assessments will be conducted at baseline and 6 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosyphilisStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680011
- Sponsor's protocol ID
- smhcgxy_2
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis
- ClinicalTrials.gov ID
- NCT06680011
- Acronym / sponsor ID
- smhcgxy_2
- Conditions
- Neurosyphilis, Biomarkers, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of neurosyphilis patients, non-neurosyphilis syphilis patients, and healthy controls aged 18-65.
Key inclusion criteria (16 listed)
- Neurosyphilis Patients
- Non-neurosyphilis Syphilis Patients
- Healthy Controls
Key exclusion criteria (17 listed)
- Neurosyphilis Patients \& Non-neurosyphilis Syphilis Patients
- Healthy Controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Assessment of Cognitive Function using MoCA
Time frame: Cognitive assessments will be conducted at baseline and 6 months post-enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosyphilis and Biomarkers, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyun Guo, PhD (+86 13524600458, xiaoyunguo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of AIM2 inflammasome in peripheral blood. (time frame: Data will be collected at baseline, 6 months, and 12 months after enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.