An observational study in Yaws, sponsored by London School of Hygiene and Tropical Medicine. Completed at 3 sites in 3 countries. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by London School of Hygiene and Tropical Medicine · Observational
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
London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Diagnostic Test: PCR · Diagnostic Test: LAMP
qPCR for T.pallidum
LAMP assay for T.pallidum
Sensitivity of LAMP vs qpCR
A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
Time frame: 15 Months
Specificity of LAMP for Yaws
Sample negative by qPCR for T.pallidum that is also negative by LAMP
Time frame: 15 Months
| Milestone | Suspected Yaws Cases |
|---|---|
| Started | 563 |
| Completed | 525 |
| Not completed | 38 |
A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
| Percent | Serologically Confirmed Yaws |
|---|---|
| Sensitivity of LAMP vs qpCR | 63.2 (60.6 to 70.9) |
Sample negative by qPCR for T.pallidum that is also negative by LAMP
| Percent | Serologically Confirmed Yaws |
|---|---|
| Specificity of LAMP for Yaws | 67.1 (61.6 to 72.8) |
Collected over This is a diagnostic accuracy study without collection of data on AE/SAEs. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Suspected Yaws Cases | — | — | — |
| Age, Categorical(Participants) | Suspected Yaws Cases |
|---|---|
| <=18 years | 525 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Suspected Yaws Cases |
|---|---|
| Female | 149 |
| Male | 376 |
| Ethnicity (NIH/OMB)(Participants) | Suspected Yaws Cases |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 525 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Suspected Yaws Cases |
|---|---|
| Cameroon | 20 |
| Côte D'Ivoire | 93 |
| Ghana | 408 |
| Congo | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Mar 2021 to primary completion in Sep 2023, 30 months.
Results were first posted in Mar 2025, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Yaws
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