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Global Syphilis Sequencing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709862
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Wellcome Sanger Institute
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Study Description
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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.


Condition or disease Intervention/treatment
Syphilis Diagnostic Test: Whole Genome Sequencing

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Whole Genome Sequencing of Syphilis Using Routine Clinical Samples
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Residual DNA from routine clinical samples (lesion swabs/serum) of patients with Syphilis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Diagnosis of syphilis

Exclusion Criteria:

  • No PCR positive clinical sample
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709862


Locations
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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, United Kingdom
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Wellcome Sanger Institute
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03709862    
Other Study ID Numbers: 16014
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syphilis
Treponemal Infections
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Communicable Diseases