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Immune System Modulation and Outcome in High-risk cSCC Treated With Surgery and Radiotherapy

NCT05246228 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2022-02-18

No results posted yet for this study

Summary

Treatment with adjuvant radiotherapy modulates immune system in many diseases as witnessed by dynamic changes of humoral and cellular immunity. Moreover, the persistent lymphopenia after radiation therapy is a negative prognostic factor. This study is aimed to explore the changes in immune-cell populations during radiotherapy given as adjuvant treatment for high-risk cutaneous squamous cell carcinomas and to correlate them with patient's outcome.

Conditions

  • Squamous Cell Carcinoma of the Skin

Interventions

OTHER

Peripheral blood sampling in order to evaluate changes in the circulating immune population

Eveluation: circulating T cells CD3+CD8+ and CD3+CD4+, absolute lymphocyte count (ALC) and neutrophil counts (ANC) and neutrophil/lymphocyte ratio (NLR), Treg lymphocytes, Naïve/Memory T lymphocytes CD4+ and CD8+,myeloid-derived suppressor cells, Plasmacytoid Dendritic Cells NK cells dimension and bright, NKT cells, Myeloid Dendritic cells, Monocytes subsets, B lymphocytes ,Analysis of plasma cytokines (TNFalpha, TGFbeta, IL-6, IL-10) by ELISA,FN signature: real-time PCR on mRNA from peripheral blood mononuclear cells (PBMCs)

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • Istituti Ospitalieri di Cremona

    collaborator OTHER

  • IRCCS Sacro Cuore Don Calabria di Negrar

    collaborator OTHER

  • ASST Bergamo Ovest

    collaborator OTHER

  • San Gerardo Hospital

    collaborator OTHER

  • ASST Valcamonica

    collaborator UNKNOWN

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Paolo Bossi, MD · ASST Spedali Civili

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-11-30
Completion
2025-12-30

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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 NCT05246228 on ClinicalTrials.gov