Blood cancer affecting the skin
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria at all visits: 1. Able to understand and provide a written informed consent prior to any study procedures 2. Male or female subjects, 18 years or older. 3. A confirmed diagnosis of CTCL (MF type or SS type), and stage classification via histology or clinico-histopathological correlation. 4. For the stage IA-IIA CTCL patients: at least one patch and/or one plaque lesion are present, with at least one dimension with a diameter of >=3 cm. For the stage IIB and higher classified (non-tumour) CTCL patients: at least one patch and/or one plaque lesion are present, with at least one dimension with a diameter of >=3 cm For the stage IIB and higher classified (tumour) CTCL patients: at least one tumour is present, with at least one dimension with a diameter of >=1.5 cm. For the Sezary Syndrome patients: at least one patch and/or one plaque lesion are present, with at least one dimension with a diameter of >=3 cm OR at least one tumour is present, with at least one dimension with a diameter of >=1.5 cm.
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: 1. Use of topical antibiotic (on selected target lesions) and/or oral antibiotic therapy in the previous 14 days before the visit. 2. Clinically significant skin disease on the selected lesions, other than CTCL or CTCL associated secondary impetiginisation, as judged by the investigator. 3. Ongoing active skin infection, other than secondary impetiginized CTCL lesions. 4. Treatment of selected target CTCL lesions with radiotherapy within 8 weeks prior to Day 1. 5. Any other clinical condition that may preclude participation in the study as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Microbiome composition of skin lesions (target lesions, nares and non-lesional skin) • Bacterial colonisation via semi-quantitative bacterial culture samples for S. aureus • Correlation of microbiome and culture results with clinical CTCL symptoms and their intra- and inter-patient variability. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.a. | — |
Countries
Netherlands
Outcome results
None listed