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

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

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

Conditions
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Mycosis Fungoides, Sezary Syndrome

Intervention / Treatment
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* Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Mycosis fungoides and Sézary syndrome<br> | Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.<br>* 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.<br>|
| Healthy volontaires<br> | Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at baseline. | 
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at month 6. | 
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at month 12. | 
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at month 18. | 
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at month 24. | 
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at month 30. | 
| Identification of serum-protein markers. | Analysis of blood samples. | Blood samples are taken at month 36. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at baseline. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at month 6. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at month 12. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at month 18. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at month 24. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at month 30. | 
| Identification of immune cell profile-protein markers. | Analysis of blood samples. | Blood samples are taken at month 36. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at baseline. | 
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at month 6. | 
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at month 12. | 
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at month 18. | 
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at month 24. | 
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at month 30. | 
| Analysis of the lymphoma microenvironment in skin. | Analysis of lymphocyte subsets in blood. | Blood samples are taken at month 36. | 
| Skin barrier and skin microbiology profile. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Analysis of fresh blood. | Blood samples are taken at baseline. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 3. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 6. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 9. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 12. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 15. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 18. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 21. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 24. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 27. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 30. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 33. | 
| Epigenetic changes in lymphoma T cells and host T cells. | Analysis of fresh blood. | Blood samples are taken at month 36. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin lymphoma, Mycosis fungoides, Sezary syndrome, Translational research, Biomarkers, Treatment prediction, Lymphoma microenvironment, Skin neoplasms, Treatment