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Global Syphilis Sequencing

Whole Genome Sequencing of Syphilis Using Routine Clinical Samples

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03709862
Enrollment
726
Registered
2018-10-17
Start date
2018-10-08
Completion date
2022-02-28
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis

Brief 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.

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

Sponsors

Wellcome Sanger Institute
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of syphilis

Exclusion criteria

* No PCR positive clinical sample

Design outcomes

Primary

MeasureTime frameDescription
Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineageMeasured at baseline - time of enrollment. There are no further samples or visits in the study.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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026