Immune System Modulation and Outcome in High-risk cSCC Treated With Surgery and Radiotherapy
NCT ID: NCT05246228
Last Updated: 2022-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
42 participants
OBSERVATIONAL
2022-03-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Azienda Ospedaliera di Padova
OTHER
Istituti Ospitalieri di Cremona
OTHER
IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
ASST Bergamo Ovest
OTHER
San Gerardo Hospital
OTHER
ASST Valcamonica
UNKNOWN
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Responsible Party
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Paolo Bossi
Clinical Professor
Principal Investigators
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Paolo Bossi, MD
Role: PRINCIPAL_INVESTIGATOR
ASST Spedali Civili
Central Contacts
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ASST Spedali Civili di Brescia
Identifier Type: -
Identifier Source: org_study_id
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