Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
- Conditions
- Leishmaniasis
- Interventions
- Diagnostic Test: In-house Western blot, specific for Leishmania
- Registration Number
- NCT06307171
- Lead Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Leishmaniasis cases In-house Western blot, specific for Leishmania Archived, cryo-preserved or prospectively collected samples from patients with clinically or laboratory confirmed leishmaniasis Community Controls In-house Western blot, specific for Leishmania Sera from uninfected subject archived, cryo-preserved serum sample,stored at the Tropica Biobank at the DITM, IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subjects from Italy and from Africa with negative results to two serological test for leishmaniasis. Archived, cryo-preserved serum sample from subjects with a confirmed diagnosis of Chagas' diseases, TB, leprosy, and malaria stored at the Tropica Biobank at the DITM, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona. Validation CONTROLS (VC) In-house Western blot, specific for Leishmania Serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease (n=15), or TB (n=15), or malaria (n=15) or leprosy (n=5).
- Primary Outcome Measures
Name Time Method Biomarkers from Leishmania spp Baseline Presence/Absence of a reactive immunogenic band or a pattern of reactive immunogenic bands in an in-house Western blot, specific for Leishmania cases respect to negative controls.
- Secondary Outcome Measures
Name Time Method Cross reaction Baseline Presence/Absence of cross-reaction of the identified immunogenic bands, testing serum samples of patients with malaria or TB or leprosy or Chagas' disease
ARPs in different Leishmania infantum and L. donovani strains Baseline Presence/Absence of a common or differential reactive immunogenic band/pattern in different Leishmania infantum and Leishmania donovani strains from different geographical areas.
Trial Locations
- Locations (1)
IRCCS Sacro Cuore Don Calabria hospital
🇮🇹Negrar, Verona, Italy