Diagnostic Classifier for Cutaneous T-cell Lymphomas

Study Overview
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Brief Summary
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Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early and correct diagnosis of MF has very important implications for the patient. However, diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6 (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made. For this reason, a test to distinguishing early MF from benign inflammatory conditions is urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients with MF, eczema and psoriasis, the investigators want to develop a classifier system that can distinguish early MF from benign inflammatory skin diseases.

Official Title
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Diagnostic Classifier for Cutaneous T-cell Lymphomas

Conditions
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CTCL/ Mycosis Fungoides

Intervention / Treatment
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* Diagnostic Test: Skin suction blistering and skin biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and/or histopathological diagnosis of MF, eczema or psoriasis Healthy control subjects without personal history of MF, eczema or psoriasis Exclusion Criteria: Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for systemic treatments) Ongoing other treatment that might, in the opinion of the investigator, influence proteomic features of the samples to be acquired

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mycosis fungoides (MF)<br> | Diagnostic Test: Skin suction blistering and skin biopsies<br>* Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.<br>|
| Eczema (Atopic Dermatitis)<br> | Diagnostic Test: Skin suction blistering and skin biopsies<br>* Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.<br>|
| Chronic Plaque-Psoriasis<br> | Diagnostic Test: Skin suction blistering and skin biopsies<br>* Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.<br>|
| Healthy Control Skin<br> | Diagnostic Test: Skin suction blistering and skin biopsies<br>* Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin | Proteomic multiplex assay | At baseline |