A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

• Conditions: Colorectal Cancer; Surgery

• Registration Number: NCT05086601
• Lead Sponsor: Fudan University

Brief Summary

This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.

Detailed Description

In this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. The investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. The investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-03
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• Pathologically diagnosed as colorectal cancer
• Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

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Exclusion Criteria

• The patient refused to join the study
• The patient refused to collect the biological sample
• The patient refused to follow up

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival time	2 yeas after surgery	For patients received radical resection of colorectal cancer, disease-free survival time is defined as time from the surgery to any recurrence of disease or death, recorded in months.

Secondary Outcome Measures

Name	Time	Method
Overall survival time	2 yeas after surgery	Overall survival time is defined as time from the surgery to death, recorded in months.
Pathological TNM stage	1 month after surgery	The pathological TNM stage included the pathological T stage, pathological N stage and M stage. The pathological T and N stage is decided according to the removed specimen of the primary tumor by the pathologist after surgery. The M stage is decided according to the imaging tests as CT, MRI and PET-CT.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China