Identifying biomarkers for Leishmaniasis infections

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

This study is trying to find specific markers in blood samples that can help identify Leishmaniasis infections in people, including those who are infected and those who are not.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar (Academic / other)
• Locations: 1 site (Negrar, Verona)
• Trial ID: NCT06307171 on ClinicalTrials.gov

What this trial studies

This exploratory study aims to analyze archived and prospectively collected serum and blood samples to identify specific biomarkers for Leishmaniasis. The research focuses on developing accurate serological tests that do not cross-react with other infectious diseases. It also seeks to understand the Antigen Recognition Patterns (ARPs) of Leishmania infections in humans and to determine if these patterns and biomarkers are consistent across different strains of Leishmania from various regions, including Italy and Sudan. The study involves both Leishmania positive patients and community controls without the infection.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a clinically or laboratory confirmed diagnosis of Leishmaniasis from Italy or Sudan.

Not a fit: Patients under 18 years old or those without the necessary biological samples or data will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnostic tests for Leishmaniasis, improving patient outcomes through timely and precise treatment.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in identifying biomarkers for infectious diseases, suggesting potential for success.

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.

Where this trial is running

Negrar, Verona

• IRCCS Sacro Cuore Don Calabria hospital — Negrar, Verona, Italy (Recruiting)

Conditions Leishmaniasis