Skin Barrier and Microbiome of CTCL Patients

NCT05827107 | Completed

• 1 other identifier: CHDR2230
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the microbiome composition of the nares, non-lesional skin and patches, plaques and tumours in lesional skin of CTCL patients, including all stages of the disease, and to correlate microbiome (including S. aureus presence) and disease severity from CTCL patients.

Conditions

Lymphoma, T-Cell, Cutaneous

Keywords

CTCL; Microbiome

Outcome Measures

Primary Outcomes (3)

• Microbiome composition of skin lesions (target lesions, nares and non-lesional skin)

  baseline visit

• Bacterial colonisation via semi-quantitative bacterial culture samples for S. aureus

  baseline visit

• Correlation of microbiome and culture results with clinical CTCL symptoms and their intra- and inter-patient variability.

  baseline visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Mycosis fungoides and Sézary syndrome of all stages will be recruited via the patient out clinic for cutaneous lymphoma in the Leiden University Medical Centre.

You may qualify if:

• Able to understand and provide a written informed consent prior to any study procedures.
• Male or female subjects, 18 years or older.
• A confirmed diagnosis of CTCL (MF type or SS type) and stage classification via histology or clinico-histopathological correlation.
• 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 CTCL patients: at least one tumour is present, with at least one dimension with a diameter of ≥1.5 cm.

You may not qualify if:

• Use of topical antibiotic (on selected target lesions) and/or oral antibiotic therapy in the previous 14 days before the visit.
• Clinically significant skin disease on the selected lesions, other than CTCL or CTCL associated secondary impetiginisation, as judged by the investigator.
• Ongoing active skin infection, other than secondary impetiginized CTCL lesions.
• Treatment of selected target CTCL lesions with radiotherapy within 8 weeks prior to Day 1.
• Any other clinical condition that may preclude participation in the study as judged by the investigator.

Sponsors & Collaborators

• Centre for Human Drug Research, Netherlands: lead
• Leiden University Medical Center: collaborator
• Micreos: collaborator

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333CL, Netherlands

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert Rissmann, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 24, 2023
• Study Start: April 3, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

NL (1)