Clinical trial

Spatial Analysis of Host-parasite Interactions in the Skin Across the Clinical Spectrum of Cutaneous Leishmaniasis in Ethiopia

NCT05332093

Name

1451/20

Description

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.

Trial arms

Trial start

2022-03-21

Estimated PCD

2024-03-30

Trial end

2024-12-31

Status

Active (not recruiting)

Treatment

skin biopsy

4mm skin biopsy

Arms:

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

Arms:

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

Arms:

Diffuse cutaneous leishmaniasis patients group (DCL), Local cutaneous leishmaniasis patients group (LCL), Mucocutaneous leishmaniasis patients group (MCL)

skin slit

genome sequencing of parasite DNA that is extracted from the skin slit

Arms:

Diffuse cutaneous leishmaniasis patients group (DCL), Local cutaneous leishmaniasis patients group (LCL), Mucocutaneous leishmaniasis patients group (MCL)

Size

Primary endpoint

Spatially resolved immunological characterization of the CL lesion using single cell RNA sequencing and digital spatial profiling

Day 0

Genomic characterization of L. aethiopica using whole genome sequencing

Day 0

Defining microenvironment and parasite niches in CL lesions using digital spatial profiling

Day 0

Spatially resolved determination of the metabolic profile of the CL lesion using spatial OMx

Day 0

The association between host/parasite factors and patients after treatment using clinical parameters

Month 6

Eligibility criteria

Inclusion Criteria: * Willing and able to provide informed consent * Clinically confirmed CL diagnosis * Between 12 and 50 years of age Exclusion Criteria: * 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) * 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '6 Months', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, stool and skin samples will be isolated from CL patients and solely skin samples from healthy controls.'}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

Updated at

2024-04-17

1 organization

2 products

1 indication

Organization

Institute of Tropical Medicine

Product

Venous Blood Sample

Indication

Cutaneous Leishmaniasis

Product

Skin Slit