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

NCT06382844 | Recruiting

• 2 other identifiers: PI23/00486PI2023 08 1416
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Cutaneous T-Cell Lymphoma

Keywords

Lymphoma; T Cell; Cutaneous; Flow cytometry; Mycosis fungoides; Sézary syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Study Arms (4)

Cutaneous T-cell lymphoma

Patients with cutaneous T-cell lymphoma

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

Control group 1

patients with benign/reactive erythroderma

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

Control group 2

patients with systemic inflammatory processes regardless of whether they have cutaneous involvement

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

Control group 3

healthy adult subjects, age- and sex-matched with patients

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

Interventions

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

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

Control group 1; Control group 2; Control group 3; Cutaneous T-cell lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with cutaneous T-cell lymphoma
• Over 18 years old
• Sign the informed consent

You may not qualify if:

• Under 18 years old
• Do not sign the informed consent

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Instituto de Investigación Biomédica de Salamanca (IBSAL)

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphoma; Mycosis Fungoides; Sezary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julia M Almeida Parra, Prof.

  Instituto de Investigación Biomédica de Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia M Almeida Parra, Prof.

CONTACT

+34 923 29 45 00; jalmeida@usal.es

Ricardo López Pérez, PhD

CONTACT

+34 923 29 12 00; uicec.gestion@ibsal.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 24, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

ES (1)