NCT06307171

Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples. General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.

Conditions

• Leishmaniasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	In-house Western blot, specific for Leishmania	Sample will be collected at the collaborating centres and at the DITM, if not already stored at -80°C. The samples will be delivered to the DITM. For the CONTROL groups, two serological tests for Leishmaniasis, based on different antigenic fraction, will be performed on serum samples. Different strains of Leishmania infantum and Leishmania donovani will be cultivated axenically at the DITM. Whole soluble fraction of promastigote (WSF), the whole membrane protein fraction (WMF) and the whole soluble fraction secreted by promastigotes (WSFe) of Leishmania spp. will be obtained and the ARPs from WSF, WMF and WSFe, of each Leishmania will be checked trough Western-blot analysis testing at a final dilution of 1/100 each serum sample. The predominant bands detected by Western-blot analysis will be identified by SDS-PAGE separation. Selected bands, corresponding to the immunogenic bands, will be excised, digested and identified with Mass Spectrometry analysis.

Timeline

• Start date: 2023-05-22
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: Italy