Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome (BIO-MUSE): Protocol for a Translational Study.
Emma Belfrage, Sara Ek, Åsa Johansson...
https://pubmed.ncbi.nlm.nih.gov/38436589/Actively Recruiting
Led by Lund University Hospital · Updated on 2025-03-10
120
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are conducting an observational study to identify prognostic and treatment-predictive biomarkers in patients with Mycosis fungoides and Se9zary syndrome. These are types of lymphoma affecting the skin, and the study aims to better understand how blood and skin markers relate to disease progression and treatment response. The study is sponsored by Lund University Hospital and includes both patients and healthy volunteers for comparison. Participants will undergo regular blood tests and skin analyses to study the lymphoma microenvironment, skin barrier, and microbiology profile. These samples are collected systematically from the start of the study through up to three years. Treatments for participants continue as per standard clinical care, without alteration for the study. During the study visits at baseline and at months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36, blood samples and skin assessments are performed to track protein markers, immune profiles, epigenetic changes, and skin characteristics. Researchers will measure these markers repeatedly over time to understand their role in disease outcomes. Participants will be monitored throughout the study period, which may last up to three years.
CONDITIONS
Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
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Lund University Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo blood tests and analysis of the lymphoma microenvironment in skin, skin barrier, and skin microbiology profile at multiple timepoints.
Visits at baseline and every 3 to 6 months up to 36 months
Duration - Up to 3 years
Participants are observed with repeated assessments to identify predictive and prognostic biomarkers while receiving routine clinical care.
Regular visits aligned with diagnostic evaluations up to month 36
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Emma Belfrage, Sara Ek, Åsa Johansson...
https://pubmed.ncbi.nlm.nih.gov/38436589/Lund University Hospital
Lead Sponsor