Cutaneous LeishmaniasesSpatialCLNCT05332093
Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
Trial summary
Cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions. Knowledge on the host-parasite interactions underpinning the different clinical presentations is scarce, in particular for L. aethiopica infections where disease can be extremely severe. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- skin biopsy, venous blood sample (plasma, PBMC, WB) and venous blood sample (HLA)
- How many people
- 92 participants
- Where
- 1 siteEthiopia
- Study dates
- 21 Mar 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 50 years
- All sexes
- Child, Adult
Study population: Patients presenting at the LRTC and Boru Meda Hospital with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients.
Who may be able to join
- Willing and able to provide informed consent
- Clinically confirmed CL diagnosis
- Between 12 and 50 years of age
Who cannot join
- Difficult or too painful sampling zone (see skin biopsy procedure below)
- (Primary) lesion size < 1 cm
- Already receiving CL treatment or received CL treatment in the last 3 months (excluding traditional medicine)
- Known major comorbidity at time of diagnosis (e.g. VL, HIV, TB, malaria, severe intestinal helminth infection)
- Medical history of VL
- Severely underweight (BMI<16)
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- Known pregnancy
- Use of immunosuppressive medication in the last month
- Known excessive alcohol use (between >10 intakes/day and >10 intakes/week)
- History of hypersensitivity to local anaesthetics
- Presence of keloids/hypertrophic scars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spatial Analysis of Host-parasite Interactions in the Skin Across the Clinical Spectrum of Cutaneous Leishmaniasis in Ethiopia
Cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions. Knowledge on the host-parasite interactions underpinning the different clinical presentations is scarce, in particular for L. aethiopica infections where disease can be extremely severe. Our aim is to define differences in skin immune responses and parasite virulence in CL patients at single cell/parasite level and how it underpins the different clinical presentations (localised, mucocutaneous and diffuse), by producing the first spatially-resolved 'ecological' map of the lesions.
Read the detailed description
Specific objectives:
- To profile the full heterogeneity in skin and lesion immunity (single cell RNAseq), and the cellular microenvironment surrounding infected and non-infected macrophages (digital spatial profiling).
- To study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations (whole genome sequencing).
- To understand how parasites respond to the microenvironmental conditions and define parasite survival niches (digital spatial profiling).
- Study metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) (SpatialOMx).
- To investigate the association between patient outcomes and the above host/parasite factors at baseline.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- skin biopsy, venous blood sample (plasma, PBMC, WB), venous blood sample (HLA), skin slit
- Keywords
- leishmania, leishmaniasis, cutaneous leishmaniasis, neglected tropical disease, immunoparasitology
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyDiagnostic test
4mm skin biopsy
venous blood sample (plasma, PBMC, WB)Diagnostic test
venous blood sample to acquire plasma, PBMCs and whole blood
venous blood sample (HLA)Genetic
venous blood sample used for HLA typing
skin slitGenetic
genome sequencing of parasite DNA that is extracted from the skin slit
| Study group | Role | What they receive |
|---|---|---|
| Local cutaneous leishmaniasis patients group (LCL) | local cutaneous leishmaniasis patients Receives: Diagnostic Test: skin biopsy; Diagnostic Test: venous blood sample (plasma, PBMC, WB); Genetic: venous blood sample (HLA); Genetic: skin slit | |
| Mucocutaneous leishmaniasis patients group (MCL) | mucocutaneous leishmaniasis patients Receives: Diagnostic Test: skin biopsy; Diagnostic Test: venous blood sample (plasma, PBMC, WB); Genetic: venous blood sample (HLA); Genetic: skin slit | |
| Diffuse cutaneous leishmaniasis patients group (DCL) | diffuse cutaneous leishmaniasis patients Receives: Diagnostic Test: skin biopsy; Diagnostic Test: venous blood sample (plasma, PBMC, WB); Genetic: venous blood sample (HLA); Genetic: skin slit | |
| Healthy control patients group Ethiopia (HC - Ethiopia) | healthy control patients undergoing elective surgery in Northern Ethiopia Receives: Diagnostic Test: skin biopsy | |
| Healthy control patients group Belgium (HC - Belgium) | healthy control patients undergoing plastic surgery in Belgium Receives: Diagnostic Test: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatially resolved immunological characterization of the CL lesion using single cell RNA sequencing and digital spatial profiling
Using single cell RNA sequencing and digital spatial profiling methods, we will profile the full heterogeneity in healthy skin/lesion immunity and the cellular microenvironment surrounding infected and non-infected macrophages, respectively.
Measured: Day 0
Genomic characterization of L. aethiopica using whole genome sequencing
Whole genome sequencing will allow us to study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations.
Measured: Day 0
Defining microenvironment and parasite niches in CL lesions using digital spatial profiling
The digital spatial profiling will indicate the different microenvironmental conditions and parasite survival niches.
Measured: Day 0
Spatially resolved determination of the metabolic profile of the CL lesion using spatial OMx
The metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) will be studied by SpatialOMx.
Measured: Day 0
The association between host/parasite factors and patients after treatment using clinical parameters
Patients are clinically assessed at day 0 (baseline visit), day 28 and month 6. These clinical assessments include a medical questionnaire and lesion assessment, and are compared with the single cell RNA sequencing and spatial resolution data to define potential causal relations between patient outcomes and immunometabolic factors.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start21 Mar 2022
- Primary completion30 Mar 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar, University of York, Maastricht University, University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Wim Adriaensen, PhD, Principal investigator, Institute of Tropical Medicine AntwerpMikias Woldetensay, MD, Principal investigator, University of Gondar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332093
- Sponsor's protocol ID
- 1451/20
- Acronym
- SpatialCL
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD accessible by managed access
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Analysis of Host-parasite Interactions in the Skin Across the Clinical Spectrum of Cutaneous Leishmaniasis in Ethiopia
- ClinicalTrials.gov ID
- NCT05332093
- Acronym / sponsor ID
- SpatialCL / 1451/20
- Conditions
- Cutaneous Leishmaniases
- Keywords
- leishmania, leishmaniasis, cutaneous leishmaniasis, neglected tropical disease, immunoparasitology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Gondar, University of York, Maastricht University, University Hospital, Antwerp
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Apr 2022 (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.
Cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions. Knowledge on the host-parasite interactions underpinning the different clinical presentations is scarce, in particular for L. aethiopica infections where disease can be extremely severe. Our aim is to define differences in skin immune responses and parasite virulence in CL patients at single cell/parasite level and how it underpins the different clinical presentations (localised, mucocutaneous and diffuse), by producing the first spatially-resolved 'ecological' map of the lesions.
Detailed description
Specific objectives:
- To profile the full heterogeneity in skin and lesion immunity (single cell RNAseq), and the cellular microenvironment surrounding infected and non-infected macrophages (digital spatial profiling).
- To study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations (whole genome sequencing).
- To understand how parasites respond to the microenvironmental conditions and define parasite survival niches (digital spatial profiling).
- Study metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) (SpatialOMx).
- To investigate the association between patient outcomes and the above host/parasite factors at baseline.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Local cutaneous leishmaniasis patients group (LCL) | – | Diagnostic Test: skin biopsy, Diagnostic Test: venous blood sample (plasma, PBMC, WB), Genetic: venous blood sample (HLA), Genetic: skin slitlocal cutaneous leishmaniasis patients |
| Mucocutaneous leishmaniasis patients group (MCL) | – | Diagnostic Test: skin biopsy, Diagnostic Test: venous blood sample (plasma, PBMC, WB), Genetic: venous blood sample (HLA), Genetic: skin slitmucocutaneous leishmaniasis patients |
| Diffuse cutaneous leishmaniasis patients group (DCL) | – | Diagnostic Test: skin biopsy, Diagnostic Test: venous blood sample (plasma, PBMC, WB), Genetic: venous blood sample (HLA), Genetic: skin slitdiffuse cutaneous leishmaniasis patients |
| Healthy control patients group Ethiopia (HC - Ethiopia) | – | Diagnostic Test: skin biopsyhealthy control patients undergoing elective surgery in Northern Ethiopia |
| Healthy control patients group Belgium (HC - Belgium) | – | Diagnostic Test: skin biopsyhealthy control patients undergoing plastic surgery in Belgium |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients presenting at the LRTC and Boru Meda Hospital with clinically suspected CL during the study period will be screened for eligibility. Suspicion for CL is assessed by physicians as per routine care. In general, children are included in the study population since they are commonly affected, and also make up the majority of DCL patients.
Key inclusion criteria (3 listed)
- Willing and able to provide informed consent
- Clinically confirmed CL diagnosis
- Between 12 and 50 years of age
Key exclusion criteria (11 listed)
- Difficult or too painful sampling zone (see skin biopsy procedure below)
- (Primary) lesion size < 1 cm
- Already receiving CL treatment or received CL treatment in the last 3 months (excluding traditional medicine)
- Known major comorbidity at time of diagnosis (e.g. VL, HIV, TB, malaria, severe intestinal helminth infection)
- Medical history of VL
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 |
|---|---|---|
| skin biopsy4mm skin biopsy | Diagnostic test | Diffuse cutaneous leishmaniasis patients group (DCL), Healthy control patients group Belgium (HC - Belgium), Healthy control patients group Ethiopia (HC - Ethiopia), Local cutaneous leishmaniasis patients group (LCL), Mucocutaneous leishmaniasis patients group (MCL) |
| venous blood sample (plasma, PBMC, WB)venous blood sample to acquire plasma, PBMCs and whole blood | Diagnostic test | Diffuse cutaneous leishmaniasis patients group (DCL), Local cutaneous leishmaniasis patients group (LCL), Mucocutaneous leishmaniasis patients group (MCL) |
| venous blood sample (HLA)venous blood sample used for HLA typing | Genetic | Diffuse cutaneous leishmaniasis patients group (DCL), Local cutaneous leishmaniasis patients group (LCL), Mucocutaneous leishmaniasis patients group (MCL) |
| skin slitgenome sequencing of parasite DNA that is extracted from the skin slit | Genetic | Diffuse cutaneous leishmaniasis patients group (DCL), Local cutaneous leishmaniasis patients group (LCL), Mucocutaneous leishmaniasis patients group (MCL) |
Primary outcome
Spatially resolved immunological characterization of the CL lesion using single cell RNA sequencing and digital spatial profiling
Time frame: Day 0
Using single cell RNA sequencing and digital spatial profiling methods, we will profile the full heterogeneity in healthy skin/lesion immunity and the cellular microenvironment surrounding infected and non-infected macrophages, respectively.
Genomic characterization of L. aethiopica using whole genome sequencing
Time frame: Day 0
Whole genome sequencing will allow us to study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations.
Defining microenvironment and parasite niches in CL lesions using digital spatial profiling
Time frame: Day 0
The digital spatial profiling will indicate the different microenvironmental conditions and parasite survival niches.
Spatially resolved determination of the metabolic profile of the CL lesion using spatial OMx
Time frame: Day 0
The metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) will be studied by SpatialOMx.
The association between host/parasite factors and patients after treatment using clinical parameters
Time frame: Month 6
Patients are clinically assessed at day 0 (baseline visit), day 28 and month 6. These clinical assessments include a medical questionnaire and lesion assessment, and are compared with the single cell RNA sequencing and spatial resolution data to define potential causal relations between patient outcomes and immunometabolic factors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Yes. IPD accessible by managed access
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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. This study is not recruiting at the moment.
Wim Adriaensen, PhD principal investigator
Institute of Tropical Medicine Antwerp
Mikias Woldetensay, MD principal investigator
University of Gondar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 9 Jan 2025. 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 Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatially resolved immunological characterization of the CL lesion using single cell RNA sequencing and digital spatial profiling (time frame: Day 0). The study lists 5 primary outcomes in all. 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 9 Jan 2025.