Prognostic Biomarker for CRC

• Conditions: Colorectal Cancer

• Registration Number: NCT03928652
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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 Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-24
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-24
• Last Update Submitted: 2019-04-24
• Study First Posted: 2019-04-26
• Last Update Posted: 2019-04-26
• Primary Completion: 2023-04
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
2. Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
3. Sufficient surgical tissue samples are available for testing;
4. untreated colon or rectal cancer patients;
5. Patient able to understand and sign written informed consent
6. No evidence of distant metastasis (M0)

Exclusion Criteria

1. Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
2. Other malignant tumors;
3. Pregnant women;
4. Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure-free Survival	3 years
Tumor regression grade	1 year	For rectal cancer patients who receive neoadjuvant treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yet-sen University; 🇨🇳 Guangzhou, China