Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome. (BIO-MUSE)

Lund University Hospital

Status: Enrolling

Conditions: Mycosis Fungoides; Sezary Syndrome

Treatments: Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Study type: Observational

Funder types: Other

Identifiers

NCT04904146

Version 1.7

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Patients with Mycosis fungoides and Sézary syndrome

Treatment:

Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Healthy volontaires

Treatment:

Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.