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Clinical Trials/NCT03928652
NCT03928652
Unknown
N/A

Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer

Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country1,050 target enrollmentApril 24, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment
1050
Locations
1
Primary Endpoint
Failure-free Survival
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 24, 2019
End Date
December 2023
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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