Global Syphilis Sequencing

Syphilis Clinical Trial

Official title:

Whole Genome Sequencing of Syphilis Using Routine Clinical Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709862
• Other study ID #: 16014
• Status: Completed
• Start date: October 8, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 726
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of syphilis

Exclusion Criteria:

• No PCR positive clinical sample

Related Conditions & MeSH terms

• Syphilis

Intervention

Diagnostic Test:
• Whole Genome Sequencing
Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Wellcome Sanger Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at baseline - time of enrollment. There are no further samples or visits in the study.