A single-centre, exploratory study to characterise the skin barrier and microbiome of patients with cutaneous T-cell lymphoma (CTCL)
- Conditions
- Blood cancer affecting the skin10014982
- Registration Number
- NL-OMON53930
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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.
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Microbiome composition of skin lesions (target lesions, nares and<br /><br>non-lesional skin)<br /><br>• Bacterial colonisation via semi-quantitative bacterial culture samples for S.<br /><br>aureus<br /><br>• Correlation of microbiome and culture results with clinical CTCL symptoms and<br /><br>their intra- and inter-patient variability.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.a.</p><br>