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
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Leishmania positive patients from Italy and Sudan with confirmed clinical or laboratory diagnosis
- Signed informed consent (not required for stored samples at Tropica Biobank)
- Classification as leishmaniasis patient by experienced clinician or positive results on at least two different serological or molecular tests
- Cryo-preserved serum samples from adults without Leishmania infection, negative to two serological tests
- Serum samples from adults clinically diagnosed with Chagas disease, tuberculosis, malaria, or leprosy who are negative to two serological tests for leishmaniasis
You will not qualify if you...
- Subjects younger than 18 years
- Lack of necessary data or biological samples
- Positive result on any serological test for leishmaniasis in control groups
- Subjects with Leishmania infection in control groups
AI-Screening
AI-Powered Screening
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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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