Global Syphilis Sequencing

NCT ID: NCT03709862

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

726 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-08

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Syphilis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Syphilis

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

Whole Genome Sequencing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Whole Genome Sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of syphilis

Exclusion Criteria

* No PCR positive clinical sample
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellcome Sanger Institute

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitals Birmingham

Birmingham, , United Kingdom

Site Status

Brighton and Sussex NHS Trust

Brighton, , United Kingdom

Site Status

Leeds University Teaching Hospital

Leeds, , United Kingdom

Site Status

Mortimer Market Centre

London, , United Kingdom

Site Status

Penine Acute Hospitals Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16014

Identifier Type: -

Identifier Source: org_study_id

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