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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-25

Study Completion Date

2026-07-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Stage IV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal Cancer Patients

Newly diagnosed stage IV colorectal cancer patients

No interventions assigned to this group

Controls

cancer free

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes