A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05086601
• Collaborator: (none)
• Enrollment: 15,000
• Location: 1
• Anticipated Duration (Months): 21.3
• Patients Per Site Per Month: 705.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Surgery	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 15000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Sep 9, 2022
• Anticipated Study Completion Date: Sep 9, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall survival time [2 yeas after surgery]

   Overall survival time is defined as time from the surgery to death, recorded in months.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fudan University
• ClinicalTrials.gov Identifier: NCT05086601
• Other Study ID Numbers: CRCC2021
• First Posted: Oct 21, 2021
• Last Update Posted: Oct 21, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Oct 21, 2021