Global Syphilis Sequencing
- Conditions
- Syphilis
- Interventions
- Diagnostic Test: Whole Genome Sequencing
- Registration Number
- NCT03709862
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 726
- Diagnosis of syphilis
- No PCR positive clinical sample
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Syphilis Whole Genome Sequencing Patients with syphilis and detectable Treponema pallidum DNA in a routinely collected clinical sample
- Primary Outcome Measures
Name Time Method Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage Measured 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Mortimer Market Centre
🇬🇧London, United Kingdom
Penine Acute Hospitals Trust
🇬🇧Manchester, United Kingdom
University Hospitals Birmingham
🇬🇧Birmingham, United Kingdom
Brighton and Sussex NHS Trust
🇬🇧Brighton, United Kingdom
Leeds University Teaching Hospital
🇬🇧Leeds, United Kingdom