Prognostic Biomarker for CRC

Colorectal Cancer Clinical Trial

— PROMOTE  

Official title:

Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03928652
• Other study ID #: Lan2019/4/24
• Status: Recruiting
• Start date: April 24, 2019
• Est. completion date: December 2023

Study information

• Verified date: April 2019
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Ping Lan, PhD
• Phone: 86-20-38254009
• Email: sumslp[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: December 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yet-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free Survival		3 years
Primary	Tumor regression grade	For rectal cancer patients who receive neoadjuvant treatment	1 year
Secondary	Overall survival		3 years