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/38436589Actively Recruiting
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID04904146
Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and S e9zary Syndrome
Led by Lund University Hospital · Updated on 2025-03-10
120
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting an observational study to identify prognostic and treatment-predictive biomarkers in patients with Mycosis fungoides and S e9zary 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
Brief Title
Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
Who Can Participate
Age: 18Years - 100Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18-100 years
- Histologically confirmed Mycosis fungoides or S�e9zary syndrome stages I-IV
- WHO performance status between 0 and 3
- No psychiatric illness affecting ability to understand the study
- Written informed consent given according to regulations
- No specific laboratory data requirements
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
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
Long-term Monitoring
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
Trial Site Locations
Total: 1 location
1
Lund University Hospital
Lund, Sweden, SE-221 85
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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