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

NCT05246228 | Unknown

• 1 other identifier: ASST Spedali Civili di Brescia
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment

  Disease-free survival (DFS) of patients with ALC \< 500 cells/mL 28 days after the end of radiotherapy treatment

  28 days after the end of radiotherapy treatment

Secondary Outcomes (1)

• Evaluation of changes (Δ) in the circulating immune-cells population before the start of radiotherapy and 28 days after the end of radiotherapy

  Before and 28 days after the end of radiotherapy treatment

Study Arms (1)

Patient with cSCC addressed to adjuvant radiotherapy as per clinical practice

The aim of the study is to evaluate patient's outcome according to the post-radiation lymphocytes count and to the changes induced in the immune cell population by a loco-regional treatment as radiotherapy. The way to objectivate these results is to collect some blood samples and analyze them.

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

Interventions

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

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)

Patient with cSCC addressed to adjuvant radiotherapy as per clinical practice

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

The patients enrolled in the study are affected form cSCC classified at high risk and addressed to surgery and subsequent adjuvant radiotherapy according to clinical practice.

You may qualify if:

• Age ≥ 18 years.
• Signed written informed consent.
• Histologically confirmed diagnosis of cSCC.
• cSCC categorized as high risk according to ASTRO Guidelines:
• close or positive margins that cannot be corrected with further surgery (secondary to morbidity or adverse cosmetic outcome).
• gross perineural spread, as identified by radiological or pathological assessment.
• disease recurrence after a prior margin-negative resection.
• pathological stage T3 and T4.
• desmoplastic or infiltrative tumors in the setting of chronic immunosuppression at pathological exam, cSCC involving regional lymphnodes, with the exception of a single, small (\<3 cm) cervical lymph node harboring carcinoma, without extracapsular extension.
• cSCC addressed to adjuvant radiotherapy as per clinical practice (a complete post-operative treatment should be administered with 50-54 or 60-66 Gy depending on the margin status).
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.

You may not qualify if:

• cSCC not eligible for surgery.
• cSCC not eligible for adjuvant radiotherapy for any condition depending on disease characteristics or patient characteristics, co-morbidities or refusal.
• Any concurrent investigational product, biologic, or hormonal therapy for cancer treatment.
• Concurrent treatment with chemotherapy for the purpose of cSCC cure.
• History or current evidence of any condition that, in the opinion of the treating investigator, might interfere with the subject's participation for the full duration of the trial.
• Any major surgery, different from that planned for the protocol, in the 15 days before the protocol starting.
• Any radiotherapy treatment in the 28 days before the protocol starting
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Azienda Ospedaliera di Padova: collaborator
• Istituti Ospitalieri di Cremona: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• ASST Bergamo Ovest: collaborator
• San Gerardo Hospital: collaborator
• ASST Valcamonica: collaborator

Related Publications (17)

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Study Officials

• Paolo Bossi, MD

  ASST Spedali Civili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Roccaro, MD

CONTACT

+39 0303996851; coordinamento.ricerca@asst-spedalicivili.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: February 18, 2022
• Study Start: March 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 18, 2022

Record last verified: 2022-02