Cutaneous T Cell Lymphoma Clinical Trial
Official title:
Evaluation of a Combination of Blood Biomarkers for the Early Diagnosis of Mycosis Fungoides
Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the
accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches
and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and
the differential diagnosis with inflammatory dermatoses is often very difficult. The
histopathological diagnosis is also difficult and delayed. Therefore, it is important to
develop biomarkers and/or a combination of biomarkers in order to improve the early
diagnostic of MF.
In a previous trial, investigators included 490 patients in a study aiming at identifying
skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be
interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later
evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This
French institutional study demonstrated that the identification by PCR of a combination of 4
blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis
of lymphoma in erythrodermic patients. This previously published study interestingly showed
that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the
blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic
tool for MF.
The aim of this study is to establishing an accurate blood diagnosis for early suspected MF
by demonstrating that newly identified biomarkers or their combination [5 cutaneous KIR
receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX,
Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)] are differentially expressed by patients with MF
and patients with inflammatory dermatoses closely resembling MF lesions.
Statistical analysis will establish the best combination of blood biomarkers allowing the
differentiation between the two groups of patients, combination that could represent a
suitable diagnostic tool for early MF.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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