YawsLAMP4YAWSNCT04753788
Evaluation of a LAMP Assay for T. Pallidum. Pertenue
An observational study of Yaws, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
Trial summary
This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Yaws
- What is being tested?
- PCR and LAMP
- How many people
- 563 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Mar 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with clinically suspected yaws lesions in Ghana, Cote d'Ivoire and Cameroon will be screened using the DPP Syphilis Screen and Confirm RDT. If positive samples will be taken for PCR and LAMP testing.
Who may be able to join
- Lesion consistent with yaws
- Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT
Who cannot join
- Unable to give consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Clinical Evaluation of a Loop-mediated Isothermal Amplification Test for Treponema Pallidum Pertenue: A Diagnostic Tool to Support Yaws Eradication
This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws
- Conditions
- Yaws
- Being tested
- PCR, LAMP
- Medical subject headings
- Yaws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRDiagnostic test
qPCR for T.pallidum
LAMPDiagnostic test
LAMP assay for T.pallidum
| Study group | Role | What they receive |
|---|---|---|
| Suspected Yaws Cases | Individuals with a lesion clinically suspected to be yaws and with evidence of positive treponemal and non-treponemal serology as assessed by point of care lateral flow tests (DPP Syphilis Screen and Confirm, Chembio) Receives: Diagnostic Test: PCR; Diagnostic Test: LAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of LAMP vs qpCR
A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
Measured: 15 Months
Specificity of LAMP for Yaws
Sample negative by qPCR for T.pallidum that is also negative by LAMP
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Mar 2021
- Primary completion23 Sep 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for YawsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Pasteur Institute abidjan, Centre Pasteur du Cameroun, Noguchi Memorial Institute for Medical Research, University of Freiburg, MAST Group - Germany, Friedrich-Loeffler-Institut, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753788
- Sponsor's protocol ID
- LSHTM-21633
- Acronym
- LAMP4YAWS
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2021
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Handley BL, Gonzalez-Beiras C, Tchatchouang S, Basing LA, Hugues KA, Bakheit M, Becherer L, Ries C, Njih Tabah E, Crucitti T, Borst N, Luert S, Frischmann S, Haerpfer T, Landmann E, Amanor I, Sylla A, Kouame-Sina MS, Ndzomo-Ngono JP, Tano A, Arhinful D, Awondo P, Ngazoa Kakou S, Eyangoh S, Addo KK, Harding-Esch EM, Knauf S, Mitja O, Marks M. LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification - protocol for a cross-sectional, observational, diagnostic accuracy study. BMJ Open. 2022 Mar 29;12(3):e058605. doi: 10.1136/bmjopen-2021-058605.
PubMed 35351731
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Loop-mediated Isothermal Amplification Test for Treponema Pallidum Pertenue: A Diagnostic Tool to Support Yaws Eradication
- ClinicalTrials.gov ID
- NCT04753788
- Acronym / sponsor ID
- LAMP4YAWS / LSHTM-21633
- Conditions
- Yaws
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Pasteur Institute abidjan, Centre Pasteur du Cameroun, Noguchi Memorial Institute for Medical Research, University of Freiburg, MAST Group - Germany, Friedrich-Loeffler-Institut, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Yaws Cases | – | Diagnostic Test: PCR, Diagnostic Test: LAMPIndividuals with a lesion clinically suspected to be yaws and with evidence of positive treponemal and non-treponemal serology as assessed by point of care lateral flow tests (DPP Syphilis Screen and Confirm, Chembio) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with clinically suspected yaws lesions in Ghana, Cote d'Ivoire and Cameroon will be screened using the DPP Syphilis Screen and Confirm RDT. If positive samples will be taken for PCR and LAMP testing.
Key inclusion criteria (2 listed)
- Lesion consistent with yaws
- Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT
Key exclusion criteria (1 listed)
- Unable to give consent
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 |
|---|---|---|
| PCRqPCR for T.pallidum | Diagnostic test | Suspected Yaws Cases |
| LAMPLAMP assay for T.pallidum | Diagnostic test | Suspected Yaws Cases |
Primary outcome
Sensitivity of LAMP vs qpCR
Time frame: 15 Months
A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
Specificity of LAMP for Yaws
Time frame: 15 Months
Sample negative by qPCR for T.pallidum that is also negative by LAMP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35351731Handley BL, Gonzalez-Beiras C, Tchatchouang S, Basing LA, Hugues KA, Bakheit M, Becherer L, Ries C, Njih Tabah E, Crucitti T, Borst N, Luert S, Frischmann S, Haerpfer T, Landmann E, Amanor I, Sylla A, Kouame-Sina MS, Ndzomo-Ngono JP, Tano A, Arhinful D, Awondo P, Ngazoa Kakou S, Eyangoh S, Addo KK, Harding-Esch EM, Knauf S, Mitja O, Marks M. LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification - protocol for a cross-sectional, observational, diagnostic accuracy study. BMJ Open. 2022 Mar 29;12(3):e058605. doi: 10.1136/bmjopen-2021-058605.
- Individual participant dataSharing planned: Yes
Related trials for Yaws
Recruiting
Strain Counter Strain and Muscle Energy Technique in Non-specific Low Back Pain
Low Back Pian
Recruiting
Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
Adhesive Capsulitis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Not yet recruiting
Integrating Mental Health Into Neglected Tropical Disease Care in Ghana
Leprosy, Lymphatic Filariases
Recruiting
Sound Sine Wave And Standard Physiotherapy In Mechanical Low Back Pain
Low Back Pain
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Yaws, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
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 2 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cameroon, Côte d’Ivoire, Ghana. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity of LAMP vs qpCR (time frame: 15 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753788, which also lists 1 linked publication.
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 24 Mar 2025.