Recruiting NCT04904146

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

— Observational Mycosis Fungoides Sezary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile..
Who it may be relevant to: Registry conditions: Mycosis Fungoides, Sezary Syndrome. Basic parameters: 18 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Sweden
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Diagnostic test Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
The study aims to perform systematic translational sampling of each patient from study start until end-of-study, or at longest for a three year period for each patient. Treatment will be performed according to clinical routine.

Identification of serum-protein markers. [Time frame: Blood samples are taken at baseline.]
Identification of serum-protein markers. [Time frame: Blood samples are taken at month 6.]
Identification of serum-protein markers. [Time frame: Blood samples are taken at month 12.]
Identification of serum-protein markers. [Time frame: Blood samples are taken at month 18.]
Identification of serum-protein markers. [Time frame: Blood samples are taken at month 24.]
Identification of serum-protein markers. [Time frame: Blood samples are taken at month 30.]
Identification of serum-protein markers. [Time frame: Blood samples are taken at month 36.]
Identification of immune cell profile-protein markers. [Time frame: Blood samples are taken at baseline.]
Identification of immune cell profile-protein markers. [Time frame: Blood samples are taken at month 6.]
Identification of immune cell profile-protein markers. [Time frame: Blood samples are taken at month 12.]

Secondary outcome measures (12)

Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at baseline.]
Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at month 6.]
Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at month 12.]
Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at month 18.]
Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at month 24.]
Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at month 30.]
Analysis of the lymphoma microenvironment in skin. [Time frame: Blood samples are taken at month 36.]
Skin barrier and skin microbiology profile. [Time frame: Is performed at baseline.]
Skin barrier and skin microbiology profile. [Time frame: Is performed at month 6.]
Skin barrier and skin microbiology profile. [Time frame: Is performed at month12.]
Skin barrier and skin microbiology profile. [Time frame: Is performed at month18.]
Skin barrier and skin microbiology profile. [Time frame: Is performed at month 24.]

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

Not applicable. No exclusion criteria are specified.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Sweden · 1 center

Belfrage E, Ek S, Johansson A, Brauner H, Sonesson A, Drott K. Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sezary Syndrome (BIO-MUSE): Protocol for a Translational Study. JMIR Res Protoc. 2024 Apr 4;13:e55723. doi: 10.2196/55723. PMID 38436589

NCT: NCT04904146 · Version 1.7