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.
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
- Are there results?
- Not yet: the study is under way
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
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
- ClinicalTrials.gov ID
- NCT04904146
- Acronym / sponsor ID
- BIO-MUSE / Version 1.7
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Keywords
- Skin lymphoma, Mycosis fungoides, Sezary syndrome, Translational research, Biomarkers, Treatment prediction, Lymphoma microenvironment, Skin neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with 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. |
| Healthy volontaires | – | Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not applicable. No exclusion criteria are specified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Healthy volontaires, Patients with Mycosis fungoides and Sézary syndrome |
Primary outcome
Identification of serum-protein markers.
Time frame: Blood samples are taken at baseline.
Analysis of blood samples.
Identification of serum-protein markers.
Time frame: Blood samples are taken at month 6.
Analysis of blood samples.
Identification of serum-protein markers.
Time frame: Blood samples are taken at month 12.
Analysis of blood samples.
Identification of serum-protein markers.
Time frame: Blood samples are taken at month 18.
Analysis of blood samples.
Identification of serum-protein markers.
Time frame: Blood samples are taken at month 24.
Analysis of blood samples.
Identification of serum-protein markers.
Time frame: Blood samples are taken at month 30.
Analysis of blood samples.
Identification of serum-protein markers.
Time frame: Blood samples are taken at month 36.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at baseline.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at month 6.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at month 12.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at month 18.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at month 24.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at month 30.
Analysis of blood samples.
Identification of immune cell profile-protein markers.
Time frame: Blood samples are taken at month 36.
Analysis of blood samples.
27 secondary outcomes
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.
Skin barrier and skin microbiology profile.
Time frame: Is performed at month 30.
Skin barrier and skin microbiology profile.
Time frame: Is performed at month 36.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at baseline.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 3.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 6.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 9.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 12.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 15.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 18.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 21.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 24.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 27.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 30.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 33.
Epigenetic changes in lymphoma T cells and host T cells.
Time frame: Blood samples are taken at month 36.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 38436589Belfrage 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycosis Fungoides and Sezary Syndrome, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of serum-protein markers. (time frame: Blood samples are taken at baseline.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.