A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086601
• Other study ID #: CRCC2021
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: September 9, 2022

Study information

• Verified date: March 2021
• Source: Fudan University
• Contact: Jianmin Xu, Prof.
• Phone: +86-021-64041990
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Intervention

Procedure:
• colorectal cancer surgery
Any surgery for primary tumor of colorectal cancer, including palliative resection, simple bowel stoma and exploratory surgery.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival time	Overall survival time is defined as time from the surgery to death, recorded in months.	2 yeas after surgery
Secondary	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