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

NCT06382844 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-05-01

No results posted yet for this study

Summary

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).

Conditions

  • Cutaneous T-Cell Lymphoma

Interventions

DIAGNOSTIC_TEST

Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS).

Specific, sensitive, and reproducible (blood) detection and quantitation of tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS)

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Instituto de Investigación Biomédica de Salamanca

    lead OTHER

Principal Investigators

  • Julia M Almeida Parra, Prof. · Instituto de Investigación Biomédica de Salamanca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382844 on ClinicalTrials.gov