Clinical trial NCT06307171: Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
Official title: Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leishmaniasis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: Biomarkers from Leishmania spp
timeFrame: Baseline
Secondary outcomes:
measure: ARPs in different Leishmania infantum and L. donovani strains
timeFrame: Baseline
measure: Cross reaction
timeFrame: Baseline
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References: