Global Syphilis Sequencing

• Sponsor: London School of Hygiene and Tropical Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03709862
• Collaborator: Wellcome Sanger Institute (Other)
• Enrollment: 726
• Locations: 5
• Actual Duration (Months): 40.7
• Patients Per Site: 145.2
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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	Phase
Syphilis	Diagnostic Test: Whole Genome Sequencing

Study Design

• Study Type: Observational
• Actual Enrollment: 726 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Whole Genome Sequencing of Syphilis Using Routine Clinical Samples
• Actual Study Start Date: Oct 8, 2018
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Feb 28, 2022

Arms and Interventions

Arm	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

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of syphilis

Exclusion Criteria:

• No PCR positive clinical sample

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Birmingham	Birmingham		United Kingdom
2	Brighton and Sussex NHS Trust	Brighton		United Kingdom
3	Leeds University Teaching Hospital	Leeds		United Kingdom
4	Mortimer Market Centre	London		United Kingdom
5	Penine Acute Hospitals Trust	Manchester		United Kingdom

Sponsors and Collaborators

• London School of Hygiene and Tropical Medicine
• Wellcome Sanger Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT03709862
• Other Study ID Numbers: 16014
• First Posted: Oct 17, 2018
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Syphilis

Study Results

No Results Posted as of Apr 12, 2022