Global Syphilis Sequencing

April 11, 2022 updated by: London School of Hygiene and Tropical Medicine

Whole Genome Sequencing of Syphilis Using Routine Clinical Samples

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

726

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Diagnosis of syphilis

Exclusion Criteria:

  • No PCR positive clinical sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Syphilis
Patients with syphilis and detectable Treponema pallidum DNA in a routinely collected clinical sample
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage
Time Frame: 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.
Measured at baseline - time of enrollment. There are no further samples or visits in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Wellcome Sanger Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

February 28, 2022

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (ACTUAL)

October 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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