Evaluation of the KIR3DL2 Marker in Flow Cytometry for Sézary Syndrome Diagnosis, Therapeutic Response and Residual Disease: a Prospective and Multicenter Study

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a specific marker called KIR3DL2 to help improve the diagnosis and treatment of Sézary syndrome, a type of skin cancer that affects T-cells. The study aims to see how well KIR3DL2 can identify cancerous cells in the blood, which is important for accurately staging the disease and determining how well treatments are working. By examining patients from multiple centers, researchers hope to establish KIR3DL2 as a reliable marker that can enhance patient care and treatment outcomes.

To be eligible for the trial, participants must be at least 18 years old, have health insurance, and agree to take part in the study. There are two main groups: one for patients who are being diagnosed with the disease, and another for those already diagnosed with Sézary syndrome who meet specific medical criteria. Participants can expect to provide blood samples for testing and may help researchers learn more about effective treatments. It’s important to note that individuals with certain other medical conditions or those who cannot give their consent will not be included in the study.

Gender

ALL

Eligibility criteria

• Inclusion criteria for all patient :
• • Age ≥ 18
• • Patients with health insurance
• • Patients informed and not opposed to the study
• Inclusion criteria for group 1 :
• • - Patients with clinical features consistent with erythrodermic CTCL at initial diagnosis.
• Inclusion criteria for group 2 :
• * Confirmed SS (previously diagnosed), followed at Saint Louis hospital participating center with all the following criteria:
• • 1. Stage T4 erythroderma (stage (erythrodermia ≥ 80% of total body area)
• • 2. The presence of an identical T-cell clone evidenced in blood and skin
• • 3. B2 blood staging at initial diagnosis
• Exclusion Criteria:
• • Other progressive neoplastic disease
• • Progressive psychotic disease
• • Patient under guardianship or curatorship
• • Patients with state medical aid
• • Refusal to participate