Clinical trial NCT04149613: Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer
Official title: Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer Stage IV
Keywords: biomarker
colorectal cancer
prognosis
prediction
microRNA
inflammation
dietary pattern
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of inflammatory markers
timeFrame: At diagnosis before chemotherapy
measure: microRNA expression Level
timeFrame: At diagnosis before chemotherapy
Secondary outcomes:
measure: Dietary pattern
timeFrame: At diagnosis before chemotherapy and every 3 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Sally Temraz, MD
role: PRINCIPAL_INVESTIGATOR
References: