Condition: Cutaneous T-Cell Lymphoma · Sponsor: Instituto de Investigación Biomédica de Salamanca
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 explore…
This description comes directly from the study's public registry record.
Julia M Almeida Parra, Prof. · +34 923 29 45 00 · jalmeida@usal.es
Ricardo López Pérez, PhD · +34 923 29 12 00 · uicec.gestion@ibsal.es
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| Instituto de Investigación Biomédica de Salamanca (IBSAL) | Salamanca, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06382844