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RecruitingNCT04904146BIO-MUSEUpdated Aug 27, 2026

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

An observational study in Mycosis Fungoides and Sezary Syndrome, sponsored by Lund University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Lund University Hospital · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Mycosis Fungoides
  • Sezary Syndrome

Keywords

  • Skin lymphoma
  • Mycosis fungoides
  • Sezary syndrome
  • Translational research
  • Biomarkers
  • Treatment prediction
  • Lymphoma microenvironment
  • Skin neoplasms
  • Treatment
03

In context

Mycosis Fungoides

447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 51 observational studies indexed under Mycosis Fungoides.

Browse Mycosis Fungoides studies →

Lead sponsor

Lund University Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-100 years
  • confirmed (according to the World Health Organization (WHO)/EORTC classification) MF/SS stages I-IV
  • 0 -3
  • Absence of psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.
  • Written according to International Conference on Harmonization (ICH)/(Good Clinical Practice (GCP), and Swedish regulations
  • No minimum or maximum required routine laboratory data

Exclusion criteria

Exclusion Criteria:

Not applicable. No exclusion criteria are specified.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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.

06

What researchers measure

Primary outcomes

  1. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at baseline.

  2. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 6.

  3. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 12.

  4. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 18.

  5. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 24.

  6. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 30.

  7. Identification of serum-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 36.

  8. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at baseline.

  9. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 6.

  10. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 12.

  11. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 18.

  12. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 24.

  13. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 30.

  14. Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Time frame: Blood samples are taken at month 36.

Secondary outcomes

  1. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at baseline.

  2. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at month 6.

  3. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at month 12.

  4. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at month 18.

  5. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at month 24.

  6. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at month 30.

  7. Analysis of the lymphoma microenvironment in skin.

    Analysis of lymphocyte subsets in blood.

    Time frame: Blood samples are taken at month 36.

  8. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at baseline.

  9. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at month 6.

  10. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at month12.

  11. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at month18.

  12. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at month 24.

  13. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at month 30.

  14. Skin barrier and skin microbiology profile.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

    Time frame: Is performed at month 36.

  15. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at baseline.

  16. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 3.

  17. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 6.

  18. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 9.

  19. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 12.

  20. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 15.

  21. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 18.

  22. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 21.

  23. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 24.

  24. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 27.

  25. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 30.

  26. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 33.

  27. Epigenetic changes in lymphoma T cells and host T cells.

    Analysis of fresh blood.

    Time frame: Blood samples are taken at month 36.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2021 (actual). Primary completion is estimated for Apr 2027, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2021
First posted
May 27, 2021
StartActual
Apr 2, 2021
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904146
Lead sponsor
Lund University Hospital
Responsible party
Sponsor
First posted
May 27, 2021
Start date
Apr 2, 2021
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Aug 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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