Actively Recruiting
Design, Development, and Validation of Novel Next Generation Flow Cytometry Approaches for Rapid, Specific, Sensitive, and Reproducible Detection of Tumor Cells in Cutaneous T-cell Lymphoma
Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2025-05-01
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigación Biomédica de Salamanca
Lead Sponsor
C
Carlos III Health Institute
Collaborating Sponsor
AI-Summary
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 S e9zary 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.
CONDITIONS
Brief Title
Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cutaneous T-cell lymphoma
- Over 18 years old
- Sign the informed consent
You will not qualify if you...
- Under 18 years old
- Do not sign the informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants undergo standardized next-generation flow cytometry testing to detect and quantify tumor cells in blood.
Periodic visits depending on group assignment
Duration - Up to study completion
Participants are observed to assess the progression and response to treatments based on flow cytometry results.
Follow-up visits as determined by clinical need
Trial Site Locations
Total: 1 location
1
Instituto de Investigación Biomédica de Salamanca (IBSAL)
Salamanca, Spain, 37007
Actively Recruiting
Research Team
J
Julia M Almeida Parra, Prof.
R
Ricardo López Pérez, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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