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A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Mycosis fungoides and Sézary syndrome |
| ||
| Healthy volontaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile. | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Not applicable. No exclusion criteria are specified.
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Patients with mycosis fungoides and Sézary syndrome (n=120) are recruited in the study.
As a control group, healthy volonteers (n=20) are recruited.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University Hospital | Recruiting | Lund | SE-221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38436589 | Derived | 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. |
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• Lymphocyte subpopulations:
|
| 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. |
| 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. |
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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