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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04904146

Acronym

BIO-MUSE

Enrollment

120

Registered

2021-05-27

Start date

2021-04-02

Completion date

2027-04-01

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycosis Fungoides, Sezary Syndrome

Keywords

Skin lymphoma, Mycosis fungoides, Sezary syndrome, Translational research, Biomarkers, Treatment prediction, Lymphoma microenvironment, Skin neoplasms, Treatment

Brief summary

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

Interventions

DIAGNOSTIC_TESTBlood 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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of serum-protein markers.	Blood samples are taken at baseline.	Analysis of blood samples.
Identification of immune cell profile-protein markers.	Blood samples are taken at baseline.	Analysis of blood samples.

Secondary

Measure	Time frame	Description
Analysis of the lymphoma microenvironment in skin.	Blood samples are taken at baseline.	Analysis of lymphocyte subsets in blood.
Skin barrier and skin microbiology profile.	Is performed at baseline.	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 baseline.	Analysis of fresh blood.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026