LeishmaniasisLeishmARPsNCT06307171
Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
A study testing In-house Western blot, specific for Leishmania in people with Leishmaniasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- In-house Western blot, specific for Leishmania
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- 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.
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- signed informed consent to Tropica Biobank
- adult subjects (equal or older than 18 years)
- being negative to two different serological tests for leishmaniasis
- 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
Who cannot join
- lack of the necessary data and/or of biological samples
- subjects younger than 18 years
- COMMUNITY CONTROLS:
- subjects younger than 18 years
- being positive to one serological tests for leishmaniasis.
- VALIDATION CONTROLS (VC):
- younger than 18 years
- positive result to one serological test for leishmaniasis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Silvia Longoni, +390456013111, silvia.longoni@sacrocuore.it
Silvia Longoni
About this study
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
- Leishmaniasis
- Being tested
- In-house Western blot, specific for Leishmania
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-house Western blot, specific for LeishmaniaDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Leishmaniasis cases | Other | Archived, cryo-preserved or prospectively collected samples from patients with clinically or laboratory confirmed leishmaniasis Receives: Diagnostic Test: In-house Western blot, specific for Leishmania |
| Community Controls | Other | Sera from uninfected subject archived, cryo-preserved serum sample,stored at the Tropica Biobank at the DITM, IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subjects from Italy and from Africa with negative results to two serological test for leishmaniasis. Archived, cryo-preserved serum sample from subjects with a confirmed diagnosis of Chagas' diseases, TB, leprosy, and malaria stored at the Tropica Biobank at the DITM, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona. Receives: Diagnostic Test: In-house Western blot, specific for Leishmania |
| Validation CONTROLS (VC) | Other | Serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease (n=15), or TB (n=15), or malaria (n=15) or leprosy (n=5). Receives: Diagnostic Test: In-house Western blot, specific for Leishmania |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 May 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307171
- Sponsor's protocol ID
- 2023-11
- Acronym
- LeishmARPs
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers
- ClinicalTrials.gov ID
- NCT06307171
- Acronym / sponsor ID
- LeishmARPs / 2023-11
- Conditions
- Leishmaniasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leishmaniasis cases | Other | Diagnostic Test: In-house Western blot, specific for LeishmaniaArchived, cryo-preserved or prospectively collected samples from patients with clinically or laboratory confirmed leishmaniasis |
| Community Controls | Other | Diagnostic Test: In-house Western blot, specific for LeishmaniaSera from uninfected subject archived, cryo-preserved serum sample,stored at the Tropica Biobank at the DITM, IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subjects from Italy and from Africa with negative results to two serological test for leishmaniasis. Archived, cryo-preserved serum sample from subjects with a confirmed diagnosis of Chagas' diseases, TB, leprosy, and malaria stored at the Tropica Biobank at the DITM, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona. |
| Validation CONTROLS (VC) | Other | Diagnostic Test: In-house Western blot, specific for LeishmaniaSerum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease (n=15), or TB (n=15), or malaria (n=15) or leprosy (n=5). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (8 listed)
- lack of the necessary data and/or of biological samples
- subjects younger than 18 years
- subjects younger than 18 years
- being positive to one serological tests for leishmaniasis.
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-house Western blot, specific for LeishmaniaSample 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. | Diagnostic test | Community Controls, Leishmaniasis cases, Validation CONTROLS (VC) |
Primary outcome
Biomarkers from Leishmania spp
Time frame: Baseline
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.
2 secondary outcomes
ARPs in different Leishmania infantum and L. donovani strains
Time frame: Baseline
Cross reaction
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-house Western blot, specific for Leishmania in people with Leishmaniasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers from Leishmania spp (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.