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

NCT ID: NCT04904146

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-02

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mycosis Fungoides Sezary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Mycosis fungoides and Sézary syndrome

Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Intervention Type 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.

Healthy volontaires

Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lund University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lund University Hospital

Lund, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kristina Drott, MD, PhD

Role: primary

+46 46 17 75 20

Jan Sundberg, RN

Role: backup

+46 46 17 70 34

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38436589 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Version 1.7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fresolimumab In Systemic Sclerosis
NCT01284322 COMPLETED PHASE1
Longitudinal Spatial Frequency Domain Imaging Study
NCT05672992 ACTIVE_NOT_RECRUITING NA