Stage IV colorectal cancer
Conditions
Brief summary
Type, incidence, and severity of the adverse events, Quantification of the circulating immune effectors specific for a selected panel of tumour antigens, Immunohistochemistry on formalin-fixed, paraffin-embedded tumour samples will allow to evaluate the expression of tumour-associated antigen and to characterize the immune infiltrate.
Detailed description
RFS, OS, TTP, The potential predictive role of immunological response, as assessed by ELISPOT and DTH skin test, will also be assessed., Serum sampling will be performed before the first treatment cycle and at each disease restaging up to two years after treatment, to identify whether changes in markers values eventually found will predict disease relapse., Serum sampling will also allow the evaluation of a panel of proinflammatory cytokines during and after treatment
Interventions
Sponsors
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| RFS, OS, TTP, The potential predictive role of immunological response, as assessed by ELISPOT and DTH skin test, will also be assessed., Serum sampling will be performed before the first treatment cycle and at each disease restaging up to two years after treatment, to identify whether changes in markers values eventually found will predict disease relapse., Serum sampling will also allow the evaluation of a panel of proinflammatory cytokines during and after treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Type, incidence, and severity of the adverse events, Quantification of the circulating immune effectors specific for a selected panel of tumour antigens, Immunohistochemistry on formalin-fixed, paraffin-embedded tumour samples will allow to evaluate the expression of tumour-associated antigen and to characterize the immune infiltrate. | — |
Countries
Italy
Outcome results
None listed