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

Leishmaniasis Clinical Trial

— LeishmARPs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307171
• Other study ID #: 2023-11
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leishmaniasis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers from Leishmania spp	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.	Baseline
Secondary	ARPs in different Leishmania infantum and L. donovani strains	Presence/Absence of a common or differential reactive immunogenic band/pattern in different Leishmania infantum and Leishmania donovani strains from different geographical areas.	Baseline
Secondary	Cross reaction	Presence/Absence of cross-reaction of the identified immunogenic bands, testing serum samples of patients with malaria or TB or leprosy or Chagas' disease	Baseline