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

Colorectal Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04149613
• Other study ID #: Bio-2018-0041
• Status: Enrolling by invitation
• Start date: May 25, 2018
• Est. completion date: April 18, 2024

Study information

• Verified date: July 2022
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: April 18, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Colorectal Neoplasms

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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