ClinicalTrials.gg
Active, not recruitingNCT03310424Updated Oct 5, 2023

Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

An observational study in Syphilis, sponsored by London School of Hygiene and Tropical Medicine. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by London School of Hygiene and Tropical Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
All
01

Study summary

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab.

In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.

02

Conditions studied

  • Syphilis

Browse trials for

03

In context

Syphilis

126 studies on the registry are indexed under Syphilis; 34 are open to participants now.

This study's planned enrollment of 46 is below the median of 400 across 39 observational studies indexed under Syphilis.

Browse Syphilis studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Unable to provide consent
  • Patients with other stages of syphilis apart from Primary or Secondary OR patients without a lesion from which swabs can be obtained
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo active intervention.

    No active intervention is undertaken. Collection of samples for bio-informatic analysis only

06

What researchers measure

Primary outcomes

  1. Whole Genome Sequencing

    Whole Genome Sequencing of T.pallidum

    Time frame: From samples collected at baseline

  2. Host Transcriptomic Response

    RNA Sequencing from lesion and blood samples

    Time frame: From samples collected at baseline

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310424
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Oct 27, 2017
Primary completion
Jul 30, 2019
Completion
Aug 2024 (estimated)
Last update
Oct 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion