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

NCT04149613 | Enrolling By Invitation

• 1 other identifier: Bio-2018-0041
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Stage IV

Keywords

biomarker; colorectal cancer; prognosis; prediction; microRNA; inflammation; dietary pattern

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Dietary pattern

  At diagnosis before chemotherapy and every 3 months

Study Arms (2)

Colorectal Cancer Patients

Newly diagnosed stage IV colorectal cancer patients

Controls

cancer free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Newly diagnosed Stage IV colorectal cancer
• Treatment naïve
• For the control group: adult individuals (above 18 years) with no cancer disease

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample (Plasma) before treatment

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sally Temraz, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: May 25, 2018
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

LE (1)