Actively Recruiting
Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
Led by IRCCS Sacro Cuore Don Calabria di Negrar · Updated on 2024-03-12
170
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Leishmaniasis, a parasitic infection, to identify specific biomarkers that could improve blood tests for detecting the disease. The study aims to find biomarkers that do not cross-react with other infections such as Chagas, tuberculosis, leprosy, or malaria. It also examines the Antigen Recognition Patterns (ARPs) of Leishmania infection and whether these patterns apply to different strains from Italy, Sudan, and other regions. The study involves analyzing stored and newly collected blood and serum samples from patients with confirmed Leishmaniasis, uninfected individuals, and those with other infections. Researchers use a specialized diagnostic test called Western blot to examine different protein fractions from Leishmania strains. They identify specific immunogenic proteins through laboratory techniques including mass spectrometry. Participants contribute blood samples that are tested and analyzed for biomarkers and ARPs. The study reviews these patterns at baseline to understand cross-reactions with other diseases. Samples come from multiple groups, including Leishmaniasis patients, healthy controls, and individuals with other infections. The research is observational with no assigned treatments, and participation involves providing samples and medical data. The study is expected to continue until November 2026.
CONDITIONS
Brief Title
Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients diagnosed with Leishmaniasis from Italy or Sudan confirmed by clinical or laboratory tests
- Signed informed consent or use of stored samples with consent
- Classified as leishmaniasis patients by clinicians or positive to at least two different serological or molecular tests
- Cryo-preserved serum samples from uninfected individuals with negative results to two serological tests
- Serum samples from subjects diagnosed with Chagas disease, tuberculosis, malaria, or leprosy stored in the Tropica Biobank
- Signed informed consent for Tropica Biobank samples
You will not qualify if you...
- Lack of necessary medical data or biological samples
- Individuals younger than 18 years
- Positive result to any serological test for Leishmaniasis in community controls or validation controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants provide serum samples which are tested using Western blot and other serological tests to identify antigen recognition patterns and potential biomarkers for Leishmaniasis.
1 visit (in-person) for sample collection
Trial Site Locations
Total: 1 location
1
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy, 37024
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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