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CompletedNCT03709862Updated Apr 12, 2022

Global Syphilis Sequencing

An observational study in Syphilis, sponsored by London School of Hygiene and Tropical Medicine. Completed at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by London School of Hygiene and Tropical Medicine · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
726
Ages
18 Years and older
Sex
All
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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 syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab.

In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.

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Conditions studied

  • Syphilis

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In context

Syphilis

120 studies on the registry are indexed under Syphilis; 33 are open to participants now.

This study's enrollment of 726 is above the median of 356 across 36 observational studies indexed under Syphilis.

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Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

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

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Who can participate

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

Study population

Patients presenting to sexual health services in UK with a diagnosis of syphilis.

We will identify residual T.pallidum DNA from routinely collected clinical samples held at participating clinics/hospitals. Data accompanying these samples will be anonymised and will not include patient identifiable information. Accompanying data will include: city of origin, age, gender, HIV status and sexual orientation.

Inclusion criteria

  • Diagnosis of syphilis

Exclusion criteria

Exclusion Criteria:

  • No PCR positive clinical sample
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
726 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Syphilis

    Patients with syphilis and detectable Treponema pallidum DNA in a routinely collected clinical sample

    Diagnostic Test: Whole Genome Sequencing

Interventions

  • Diagnostic testWhole Genome Sequencing

    Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis

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What researchers measure

Primary outcomes

  1. Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage

    Whole genome sequencing of UK and global syphilis samples combined with phylogenomic and population genomic analyses to determine the population structure and diversity of Treponema both regionally and in global context. Diversity will be assessed by measuring nucleotide diversity between samples and reference genomes.

    Time frame: Measured at baseline - time of enrollment. There are no further samples or visits in the study.

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Study locations

5 sites
  • University Hospitals Birmingham
    Birmingham, United Kingdom
  • Brighton and Sussex NHS Trust
    Brighton, United Kingdom
  • Leeds University Teaching Hospital
    Leeds, United Kingdom
  • Mortimer Market Centre
    London, United Kingdom
  • Penine Acute Hospitals Trust
    Manchester, United Kingdom
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03709862
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Wellcome Sanger Institute
Responsible party
Sponsor
First posted
Oct 17, 2018
Start date
Oct 8, 2018
Primary completion
Dec 31, 2020
Completion
Feb 28, 2022
Last update
Apr 12, 2022

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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