Identifying biomarkers for Leishmaniasis infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Immunogenicity screening of Leishmania vaccine candidate antigens in Ethiopian patients

  This study tests whether six Leishmania vaccine candidate antigens can trigger T-cell responses in patients with cutaneous or visceral leishmaniasis.

  Recruiting at 2 sites Institute of Tropical Medicine, Belgium · Addis Ababa and 1 other locations · NCT07783243

• Community spread of multiple infectious diseases in Cambodia from a One Health perspective

  This project will test how common and connected dengue, chikungunya, Zika, Japanese encephalitis, and West Nile infections are among people, animals, and the environment across Cambodia.

  Recruiting Institut Pasteur du Cambodge · Phnom Penh, Phnom Penh · NCT07358910

• Understanding and treating Leishmania infections

  This study is trying to better understand Leishmania infections and find the best treatments for people aged 2 to 80 who have or might have this disease.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT00344188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.