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

NCT06307171 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Phase

Not applicable

Started

2023-05-22

Last updated

2024-03-12

Condition(s) studied

Leishmaniasis

Investigational drug(s) / intervention(s)

In-house Western blot, specific for Leishmania

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06307171 on ClinicalTrials.gov ↗ ← All trials in Italy