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

Launched by IRCCS SACRO CUORE DON CALABRIA DI NEGRAR · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how to improve the testing for Leishmaniasis, a disease caused by parasites transmitted through the bite of infected sandflies. The researchers are looking for specific markers in the blood that can help create better tests to detect this infection without confusing it with other diseases, like Chagas, tuberculosis, or malaria. The study will analyze blood samples from people diagnosed with Leishmaniasis in Italy and Sudan, as well as samples from healthy individuals and those diagnosed with other diseases to ensure the new tests are accurate.

To be eligible for this trial, participants must be adults (18 years or older) and have a confirmed diagnosis of Leishmaniasis for the case group. Those in the control groups must be healthy individuals without Leishmaniasis or those diagnosed with other diseases. Participants can expect to provide blood samples and may learn more about their health through this process. The trial is currently recruiting participants, so if you or someone you know meets these criteria, this could be an opportunity to contribute to important research in understanding and diagnosing Leishmaniasis better.

Gender

ALL

Eligibility criteria

• CASES:
• Inclusion criteria:
• • Leishmania positive patient from Italy (n=30) and from Sudan (n=30);
• • patient with a clinically or laboratory confirmed diagnosis of leishmaniasis;
• • signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM)
• • being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp.
• • adult subjects (equal or older than 18 years)
• Exclusion criteria:
• • lack of the necessary data and/or of biological samples
• • subjects younger than 18 years
• COMMUNITY CONTROLS:
• Inclusion criteria:
• • Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp.
• • signed informed consent to Tropica Biobank
• • adult subjects (equal or older than 18 years)
• • being negative to two different serological tests for leishmaniasis
• Exclusion criteria:
• • subjects younger than 18 years
• • being positive to one serological tests for leishmaniasis.
• VALIDATION CONTROLS (VC):
• Inclusion criteria:
• • serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy.
• • informed consent signed to Tropical Biobank
• • adult subjects (equal or older than 18 years)
• • being negative to two different serological tests for leishmaniasis.
• • being clinically diagnosed with Chagas disease or TB, or malaria or leprosy
• Exclusion criteria:
• • younger than 18 years
• • positive result to one serological test for leishmaniasis.