Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.

Recruiting

• Conditions: Mycosis Fungoides; Sezary Syndrome
• Interventions: Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

• Registration Number: NCT04904146
• Lead Sponsor: Lund University Hospital

Brief Summary

A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-02
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age 18-100 years
• Histologically confirmed (according to the World Health Organization (WHO)/EORTC classification) MF/SS stages I-IV
• WHO performance status 0 -3
• Absence of psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.
• Written informed consent according to International Conference on Harmonization (ICH)/(Good Clinical Practice (GCP), and Swedish regulations
• No minimum or maximum required routine laboratory data

Exclusion Criteria

Not applicable. No exclusion criteria are specified.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volontaires	Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.	-
Patients with Mycosis fungoides and Sézary syndrome	Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.	-

Primary Outcome Measures

Name	Time	Method
Identification of serum-protein markers.	Blood samples are taken at month 36.	Analysis of blood samples.
Identification of immune cell profile-protein markers.	Blood samples are taken at month 36.	Analysis of blood samples.

Secondary Outcome Measures

Name	Time	Method
Analysis of the lymphoma microenvironment in skin.	Blood samples are taken at month 36.	Analysis of lymphocyte subsets in blood.
Skin barrier and skin microbiology profile.	Is performed at month 36.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Epigenetic changes in lymphoma T cells and host T cells.	Blood samples are taken at month 36.	Analysis of fresh blood.

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden