Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry).
Patients with cutaneous T-cell lymphoma
Over 18 years old
Sign the informed consent
Under 18 years old
Do not sign the informed consent
Cases of cutaneous lymphoma/reactive erythroderma will be recruited from the routine clinical practice of the Cutaneous T-Cell Lymphoma Monographic Clinic at the University Hospital of Salamanca, which is conducted in a multidisciplinary manner under the responsibility of the Dermatology and Hematology services, involving two members of the research team (ECA and MLP). Diagnosis will be made according to the current criteria of the EORTC-OMS; patients will be included both at diagnosis and at any other stage of the tumor during follow-up
Cohort
Prospective
Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).
Diagnostic testSpecific, sensitive, and reproducible (blood) detection and quantitation of tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS)
Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry
Designing an optimal marker combination for the specific identification and quantification of Sézary cells (particularly in blood) using spectral flow cytometry, enabling their discrimination from normal/reactive TCD4+ cells, and including markers for T-cell identification, T-cell maturation, aberrant markers, and markers to assess T-cell clonality
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Instituto de Investigación Biomédica de Salamanca
Lead sponsor
Carlos III Health Institute
Collaborator
