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

N/AEnrolling By InvitationNCT04149613

American University of Beirut Medical Center100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Colorectal Cancer Stage IV

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Newly diagnosed Stage IV colorectal cancer 2. Treatment naïve 3. 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: 1. Diagnosis of inflammatory bowel disease such as ulcerative colitis and crohn's disease. 2. Diagnosis of active systemic autoimmune disease 3. Chronic / recent use of corticosteroids 4. Use of immunosuppressant drugs

Locations (1)

American University of Beirut

Beirut, Lebanon

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: At diagnosis before chemotherapy

Secondary Outcomes

Dietary pattern

Associations of dietary patterns (such as the Mediterranean diet and DII) with inflammatory markers, and microRNA expression

Time frame: At diagnosis before chemotherapy and every 3 months

Data from ClinicalTrials.gov

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