SyphilisNCT03709862
Global Syphilis Sequencing
An observational study of Syphilis, run by London School of Hygiene and Tropical Medicine at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syphilis
- What is being tested?
- Whole Genome Sequencing
- How many people
- 726 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 8 Oct 2018to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of syphilis
Who cannot join
- No PCR positive clinical sample
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University Hospitals Birmingham
Birmingham
Brighton and Sussex NHS Trust
Brighton
Leeds University Teaching Hospital
Leeds
Mortimer Market Centre
London
Penine Acute Hospitals Trust
Manchester
About this study
Official title: 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.
- Conditions
- Syphilis
- Being tested
- Whole Genome Sequencing
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Genome SequencingDiagnostic test
Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis
| Study group | Role | What they receive |
|---|---|---|
| Syphilis | Patients with syphilis and detectable Treponema pallidum DNA in a routinely collected clinical sample Receives: Diagnostic Test: Whole Genome Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline - time of enrollment. There are no further samples or visits in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start8 Oct 2018
- Primary completion31 Dec 2020
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Sanger Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709862
- Sponsor's protocol ID
- 16014
- Status last verified
- Apr 2022
- First submitted
- 8 Oct 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Genome Sequencing of Syphilis Using Routine Clinical Samples
- ClinicalTrials.gov ID
- NCT03709862
- Acronym / sponsor ID
- 16014
- Conditions
- Syphilis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Wellcome Sanger Institute
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syphilis | – | Diagnostic Test: Whole Genome SequencingPatients with syphilis and detectable Treponema pallidum DNA in a routinely collected clinical sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of syphilis
Key exclusion criteria (1 listed)
- No PCR positive clinical sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Genome SequencingResidual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis | Diagnostic test | Syphilis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Syphilis
RecruitingPhase 2
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
Syphilis, Congenital
Active, not recruitingPhase 3
Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis.
Syphilis Acquired
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
RecruitingPhase 4
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Gonorrhea, Chlamydia
RecruitingPhase 2
Evaluating VM100 Nutritional Supplement for Improving Quality of Life in Duchenne Muscular Dystrophy Patients
Duchenne Muscular Dystrophy, Duchenne Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis, run by London School of Hygiene and Tropical Medicine at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.