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

February 15, 2022 updated by: Paolo Bossi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Immune System Modulation and Outcome in High-risk Cutaneous Squamous Cell Carcinoma Treated With Surgery and Radiotherapy: a Prospective Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS) of patients with ALC < 500 cells/mL 28 days after the end of radiotherapy treatment
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of changes (Δ) in the circulating immune-cells population before the start of radiotherapy and 28 days after the end of radiotherapy
Time Frame: Before and 28 days after the end of radiotherapy treatment

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

Correlation between DFS and circulating immune cell population
Before and 28 days after the end of radiotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Istituti Ospitalieri di Cremona
Azienda Ospedaliera di Padova
San Gerardo Hospital
IRCCS Sacro Cuore Don Calabria di Negrar
ASST Bergamo Ovest
ASST Valcamonica

Investigators

  • Principal Investigator: Paolo Bossi, MD, ASST Spedali Civili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

November 30, 2025

Study Completion (ANTICIPATED)

December 30, 2025

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

February 15, 2022

First Posted (ACTUAL)

February 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASST Spedali Civili di Brescia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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