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
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