Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer

Study Overview
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Brief Summary
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This study investigates the predictive and prognostic values of inflammatory markers and microRNA in stage IV colorectal cancer. The expression of inflammatory markers and microRNA in plasma will be correlated with tumor location, with dietary patterns and with survival during treatment.

Detailed Description
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Colorectal cancer (CRC) is responsible for 10% of the world-wide cancer incidence and mortality. Recent data have shown that tumors arising from different regions of the colon differ in their molecular characteristics which causes translate into a differential clinical outcome.Several studies described the role of microRNA expression in the initiation and progression of CRC and its response to different therapeutic strategies. Other studies have shown that systemic inflammation is a key determinant role of clinico-pathological outcomes in patients with CRC. We therefore aim to evaluate the expression of selected microRNA and inflammatory markers in patients with stage IV colorectal cancer and assess their correlation with tumor location, dietary patterns, survival rates, response to systemic chemotherapy and other clinic-pathological parameters. We believe that identifying a predictive and prognostic panel made up of circulating microRNA and inflammatory markers may perhaps explain the difference in outcome between right and left colon and perhaps impact the clinical practice in patients with stage IV colorectal cancer.

Official Title
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Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer

Conditions
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Colorectal Cancer Stage IV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed Stage IV colorectal cancer Treatment naïve For the control group: adult individuals (above 18 years) with no cancer disease Exclusion Criteria: Any disease or condition that may alter the inflammatory and immune status of subjects at baseline, such as: Diagnosis of inflammatory bowel disease such as ulcerative colitis and crohn's disease. Diagnosis of active systemic autoimmune disease Chronic / recent use of corticosteroids Use of immunosuppressant drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal Cancer Patients<br>Newly diagnosed stage IV colorectal cancer patients | |
| Controls<br>cancer free | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of inflammatory markers | Level of C-reactive protein (CRP), Erythrocyte sedimentation rate (ESR), serum albumin, fibrinogen, haptoglobin, lymphocyte monocyte ratio (LMR), neutrophil lymphocyte ratio (NLR) and platelets lymphocytes ratio (PLR) | At diagnosis before chemotherapy | 
| microRNA expression Level | miR-21, miR-19a, miR-155, miR-200c, miR-210, miR-126, miR-345, miR-31, miR-29a, miR-200b, and miR-203 | At diagnosis before chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary pattern | Associations of dietary patterns (such as the Mediterranean diet and DII) with inflammatory markers, and microRNA expression | At diagnosis before chemotherapy and every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, colorectal cancer, prognosis, prediction, microRNA, inflammation, dietary pattern