A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Surgery
• Intervention / Treatment: Procedure: colorectal cancer surgery

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 Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Qingyang Feng, Dr.; Phone Number: +86-021-64041990; Email: fqy198921@163.com
      • Contact: Jianmin Xu, Prof.; Email: xujmin@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients pathologically diagnosed as colorectal cancer, and receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival time	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.	2 yeas after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival time	Overall survival time is defined as time from the surgery to death, recorded in months.	2 yeas after surgery
Pathological TNM stage	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.	1 month after surgery

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): September 9, 2022
• Study Completion (Anticipated): September 9, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRCC2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No