NCT06382844 Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL
| NCT ID | NCT06382844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Biomédica de Salamanca |
| Condition | Cutaneous T-Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * Patients with cutaneous T-cell lymphoma * Over 18 years old * Sign the informed consent Exclusion Criteria: * Under 18 years old * Do not sign the informed consent
Contact & Investigator
Julia M Almeida Parra, Prof.
PRINCIPAL INVESTIGATOR
Instituto de Investigación Biomédica de Salamanca
Frequently Asked Questions
Who can join the NCT06382844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous T-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06382844 currently recruiting?
Yes, NCT06382844 is actively recruiting participants. Contact the research team at jalmeida@usal.es for enrollment information.
Where is the NCT06382844 trial being conducted?
This trial is being conducted at Salamanca, Spain.
Who is sponsoring the NCT06382844 clinical trial?
NCT06382844 is sponsored by Instituto de Investigación Biomédica de Salamanca. The principal investigator is Julia M Almeida Parra, Prof. at Instituto de Investigación Biomédica de Salamanca. The trial plans to enroll 100 participants.