Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia
NCT ID: NCT05332093
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
92 participants
OBSERVATIONAL
2022-03-21
2024-12-31
Brief Summary
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Detailed Description
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1. 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).
2. To study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations (whole genome sequencing).
3. To understand how parasites respond to the microenvironmental conditions and define parasite survival niches (digital spatial profiling).
4. 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).
5. To investigate the association between patient outcomes and the above host/parasite factors at baseline.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Local cutaneous leishmaniasis patients group (LCL)
local cutaneous leishmaniasis patients
skin biopsy
4mm skin biopsy
venous blood sample (plasma, PBMC, WB)
venous blood sample to acquire plasma, PBMCs and whole blood
venous blood sample (HLA)
venous blood sample used for HLA typing
skin slit
genome sequencing of parasite DNA that is extracted from the skin slit
Mucocutaneous leishmaniasis patients group (MCL)
mucocutaneous leishmaniasis patients
skin biopsy
4mm skin biopsy
venous blood sample (plasma, PBMC, WB)
venous blood sample to acquire plasma, PBMCs and whole blood
venous blood sample (HLA)
venous blood sample used for HLA typing
skin slit
genome sequencing of parasite DNA that is extracted from the skin slit
Diffuse cutaneous leishmaniasis patients group (DCL)
diffuse cutaneous leishmaniasis patients
skin biopsy
4mm skin biopsy
venous blood sample (plasma, PBMC, WB)
venous blood sample to acquire plasma, PBMCs and whole blood
venous blood sample (HLA)
venous blood sample used for HLA typing
skin slit
genome sequencing of parasite DNA that is extracted from the skin slit
Healthy control patients group Ethiopia (HC - Ethiopia)
healthy control patients undergoing elective surgery in Northern Ethiopia
skin biopsy
4mm skin biopsy
Healthy control patients group Belgium (HC - Belgium)
healthy control patients undergoing plastic surgery in Belgium
skin biopsy
4mm skin biopsy
Interventions
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skin biopsy
4mm skin biopsy
venous blood sample (plasma, PBMC, WB)
venous blood sample to acquire plasma, PBMCs and whole blood
venous blood sample (HLA)
venous blood sample used for HLA typing
skin slit
genome sequencing of parasite DNA that is extracted from the skin slit
Eligibility Criteria
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Inclusion Criteria
* Clinically confirmed CL diagnosis
* Between 12 and 50 years of age
Exclusion Criteria
* (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)
* 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
12 Years
50 Years
ALL
No
Sponsors
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University of Gondar
OTHER
University of York
OTHER
Maastricht University
OTHER
University Hospital, Antwerp
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Principal Investigators
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Wim Adriaensen, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Tropical Medicine Antwerp
Mikias Woldetensay, MD
Role: PRINCIPAL_INVESTIGATOR
University of Gondar
Locations
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University of Gondar
Gonder, Amhara, Ethiopia
Countries
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Other Identifiers
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1451/20
Identifier Type: -
Identifier Source: org_study_id
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