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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04149613

Enrollment

100

Registered

2019-11-04

Start date

2018-05-25

Completion date

2026-07-15

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Stage IV

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Level of inflammatory markers	At diagnosis before chemotherapy	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)
microRNA expression Level	At diagnosis before chemotherapy	miR-21, miR-19a, miR-155, miR-200c, miR-210, miR-126, miR-345, miR-31, miR-29a, miR-200b, and miR-203

Secondary

Measure	Time frame	Description
Dietary pattern	At diagnosis before chemotherapy and every 3 months	Associations of dietary patterns (such as the Mediterranean diet and DII) with inflammatory markers, and microRNA expression

Countries

Lebanon

Outcome results