Development and Validation of New Flow Cytometry Methods for Detecting Tumor Cells in Cutaneous T-Cell Lymphoma

What this Trial Is About

This research focuses on improving the detection and measurement of circulating tumor cells in patients with cutaneous T-cell lymphoma CTCL, including mycosis fungoides MF and Se9zary syndrome SS. These skin-related lymphomas are rare and challenging to diagnose, especially since skin lesions can look like non-cancerous conditions. The study aims to apply new standardized flow cytometry techniques developed by the EuroFlow Consortium to enhance the speed, accuracy, and sensitivity of tumor cell detection for better diagnosis, staging, and treatment monitoring in CTCL patients. The study uses novel next-generation flow cytometry approaches to design optimal antibody marker combinations that can distinguish tumor T lymphocytes from normal T cells. This method will be tested first on blood samples and later applied to skin samples. The project involves developing automatic data analysis strategies to reduce variability caused by individual experience. The method will be validated across multiple centers to confirm its practical use and clinical value in identifying tumor cells and assessing the immune environment around the tumor. Participants include patients with CTCL and various control groups such as patients with benign skin conditions, systemic inflammatory diseases, and healthy adults matched by age and sex. The study involves collecting blood and skin samples for flow cytometry analysis, comparing results with current gold standard techniques like PCR or next-generation sequencing. Researchers will measure how well the new method identifies and quantifies tumor cells, with a focus on the 18-month optimization of marker combinations. Participants will contribute samples and data but will not receive experimental treatments, and the study is observational in nature.

Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL