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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: Leishmaniasis

Treatments: Diagnostic Test: In-house Western blot, specific for Leishmania

Study type: Interventional

Funder types: Other

Identifiers

NCT06307171

2023-11

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

Leishmaniasis cases

Other group

Description:

Archived, cryo-preserved or prospectively collected samples from patients with clinically or laboratory confirmed leishmaniasis

Treatment:

Diagnostic Test: In-house Western blot, specific for Leishmania

Community Controls

Other group

Description:

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.

Treatment:

Diagnostic Test: In-house Western blot, specific for Leishmania

Validation CONTROLS (VC)

Other group

Description:

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).

Treatment:

Diagnostic Test: In-house Western blot, specific for Leishmania