Global Syphilis Sequencing

NCT03709862 | Completed

• 1 other identifier: 16014
• Study Type: observational
• Target: 726
• Locations: 1 country
• Sites: 5

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.

Conditions

Syphilis

Outcome Measures

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.

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

Study Arms (1)

Syphilis

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

Diagnostic Test: Whole Genome Sequencing

Interventions

Whole Genome Sequencing DIAGNOSTIC_TEST

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

Syphilis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of syphilis

You may not qualify if:

• No PCR positive clinical sample

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Wellcome Sanger Institute: collaborator

Study Sites (5)

University Hospitals Birmingham

Birmingham, United Kingdom

Location

Brighton and Sussex NHS Trust

Brighton, United Kingdom

Location

Leeds University Teaching Hospital

Leeds, United Kingdom

Location

Mortimer Market Centre

London, United Kingdom

Location

Penine Acute Hospitals Trust

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual DNA from routine clinical samples (lesion swabs/serum) of patients with Syphilis

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 17, 2018
• Study Start: October 8, 2018
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

GB (5)