Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,050
- Locations
- 1
- Primary Endpoint
- Failure-free Survival
Study Overview
Brief Summary
The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.
Detailed Description
This is a prospective observational study. Tumor tissue specimens and surgical specimens are obtained from the Sixth Affiliated Hospital, Sun Yat-sen University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death).
The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
- •Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
- •Sufficient surgical tissue samples are available for testing;
- •untreated colon or rectal cancer patients;
- •Patient able to understand and sign written informed consent
- •No evidence of distant metastasis (M0)
Exclusion Criteria
- •Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
- •Other malignant tumors;
- •Pregnant women;
- •Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
Outcomes
Primary Outcomes
Failure-free Survival
Time Frame: 3 years
Tumor regression grade
Time Frame: 1 year
For rectal cancer patients who receive neoadjuvant treatment
Secondary Outcomes
- Overall survival(3 years)