Clinical trial · Observational
Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
NCT04904146CI-TRIAL-00124256BIO-MUSErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with Mycosis fungoides and Sézary syndrome
- interventionNames
- Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
- label
- Healthy volontaires
- interventionNames
- Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
Primary outcomes (14)
- measure
- Identification of serum-protein markers.
- timeFrame
- Blood samples are taken at baseline.
- description
- Analysis of blood samples.
- measure
- Identification of serum-protein markers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBelfrage 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. PMID 38436589