Mycosis FungoidesBIO-MUSENCT04904146

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

An observational study of Mycosis Fungoides and Sezary Syndrome, run by Lund University Hospital at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

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

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Mycosis Fungoides, Sezary Syndrome
What is being tested?: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
How many people: 120 participants
Where: 1 siteSweden
Study dates: 2 Apr 2021to Apr 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Patients with mycosis fungoides and Sézary syndrome (n=120) are recruited in the study. As a control group, healthy volonteers (n=20) are recruited.

Who may be able to join

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

Who cannot join

Not applicable. No exclusion criteria are specified.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site, 1 recruiting

Lund University Hospital
Lund, SE-221 85
Kristina Drott, MD, PhD, +46 46 17 75 20, kristina.drott@med.lu.se
Jan Sundberg, RN, +46 46 17 70 34, jan.sundberg@skane.se
Recruiting

Other trials in Sweden

About this study

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

Conditions: Mycosis Fungoides, Sezary Syndrome
Being tested: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
Keywords: Skin lymphoma, Mycosis fungoides, Sezary syndrome, Translational research, Biomarkers, Treatment prediction, Lymphoma microenvironment, Skin neoplasms, Treatment
Medical subject headings: Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.Diagnostic test
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 groups in NCT04904146
Study group	Role	What they receive
Patients with Mycosis fungoides and Sézary syndrome		Not described Receives: Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
Healthy volontaires		Not described Receives: Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

What is being measured

The primary outcome is the main question the study is designed to answer.

Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at baseline.
Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 6.
Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 12.
Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 18.
Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 24.
Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 30.
Identification of serum-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 36.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at baseline.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 6.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 12.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 18.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 24.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 30.
Identification of immune cell profile-protein markers.
Analysis of blood samples.
Measured: Blood samples are taken at month 36.

Secondary outcomes (27)

Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at baseline.
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at month 6.
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at month 12.
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at month 18.
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at month 24.
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at month 30.
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Measured: Blood samples are taken at month 36.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at baseline.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at month 6.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at month12.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at month18.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at month 24.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at month 30.
Skin barrier and skin microbiology profile.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Measured: Is performed at month 36.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at baseline.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 3.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 6.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 9.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 12.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 15.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 18.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 21.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 24.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 27.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 30.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 33.
Epigenetic changes in lymphoma T cells and host T cells.
Analysis of fresh blood.
Measured: Blood samples are taken at month 36.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 2021Apr 2027

First posted27 May 2021
Study start2 Apr 2021
Primary completionApr 2027 (estimated)
Study completionApr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04904146
Sponsor's protocol ID: Version 1.7
Acronym: BIO-MUSE
Status last verified: Aug 2026
First submitted: 20 May 2021
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38436589

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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