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A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT05086601
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : September 9, 2022

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


Primary Outcome Measures :
  1. Disease-free survival time [ Time Frame: 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 [ Time Frame: 2 yeas after surgery ]
    Overall survival time is defined as time from the surgery to death, recorded in months.

  2. Pathological TNM stage [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
The specimens include primary tumor tissue, adjacent tissues, normal mucosa tissue, and peripheral venous blood. Tissue samples will be used for multiple omics tests, including genome, transcriptome, proteome, etc. Blood samples are used for tumor markers, immunology and other tests.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086601


Contacts
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Contact: Jianmin Xu, Prof. +86-021-64041990 xujmin@aliyun.com
Contact: Qingyang Feng, Dr. fqy198921@163.com

Locations
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China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Qingyang Feng, Dr.    +86-021-64041990    fqy198921@163.com   
Contact: Jianmin Xu, Prof.       xujmin@aliyun.com   
Sponsors and Collaborators
Fudan University
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Responsible Party: Fudan University
ClinicalTrials.gov Identifier: NCT05086601    
Other Study ID Numbers: CRCC2021
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases