Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome. (BIO-MUSE)

August 25, 2026 updated by: Lund University Hospital
A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-221 85
        • Recruiting
        • Lund University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kristina Drott, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

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.

Description

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 exclusion criteria are specified.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Healthy volontaires
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of serum-protein markers.
Time Frame: Blood samples are taken at baseline.
Analysis of blood samples.
Blood samples are taken at baseline.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 6.
Analysis of blood samples.
Blood samples are taken at month 6.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 12.
Analysis of blood samples.
Blood samples are taken at month 12.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 18.
Analysis of blood samples.
Blood samples are taken at month 18.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 24.
Analysis of blood samples.
Blood samples are taken at month 24.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 30.
Analysis of blood samples.
Blood samples are taken at month 30.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 36.
Analysis of blood samples.
Blood samples are taken at month 36.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at baseline.
Analysis of blood samples.
Blood samples are taken at baseline.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 6.
Analysis of blood samples.
Blood samples are taken at month 6.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 12.
Analysis of blood samples.
Blood samples are taken at month 12.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 18.
Analysis of blood samples.
Blood samples are taken at month 18.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 24.
Analysis of blood samples.
Blood samples are taken at month 24.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 30.
Analysis of blood samples.
Blood samples are taken at month 30.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 36.
Analysis of blood samples.
Blood samples are taken at month 36.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at baseline.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at baseline.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 6.
Analysis of lymphocyte subsets in blood.
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 lymphocyte subsets in blood.
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 lymphocyte subsets in blood.
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 lymphocyte subsets in blood.
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 lymphocyte subsets in blood.
Blood samples are taken at month 30.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 36.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 36.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at baseline.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at baseline.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 6.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 6.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month12.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month12.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month18.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month18.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 24.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 24.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 30.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 30.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 36.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 36.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at baseline.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
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.
Analysis of fresh blood.
Blood samples are taken at month 36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lund University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Version 1.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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