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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer Stage IV

Detailed Description

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 (Anticipated): 100

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary physicians will identify patients who are treatment naïve, stage IV colorectal cancer patients, and exclude the patients, who have a history of an inflammatory bowel disease, or an active systemic autoimmune disease, and who have a chronic / recent use of corticosteroids or on immunosuppressant drugs therapy. Recruitment will be done for patients admitted to the chemotherapy infusion unit at the Naef K. Basile Cancer Institution at the American University of Beirut Medical Center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Colorectal Cancer Patients; Newly diagnosed stage IV colorectal cancer patients
Controls; cancer free

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Sally Temraz, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2018
• Primary Completion (Anticipated): December 18, 2023
• Study Completion (Anticipated): April 18, 2024

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: colorectal cancer; biomarker; prognosis; microRNA; inflammation; prediction; dietary pattern
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Bio-2018-0041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No