The CSTME Associates With the Prognosis of Stage II and III Colorectal Cancer

Colorectal Cancer Clinical Trial

— CRC23_CSTME  

Official title:

The Tumor Microenvironment Collagen Signature (CSTME) Associates With the Prognosis of Stage II and III Colorectal Cancer : A Multi-Center Retrospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420415
• Other study ID #: NFEC22-192
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. We hypothesize that the tumor microenvironmental collagen signature of colorectal cancer is associated with prognosis.

Description:

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. In the "seed and soil" theory proposed by Stephen Paget, tumor cells play the role of the "seed", and the tumor microenvironment (TME) is the "soil". TNM classification provides useful but uncomplete prognosis information in colorectal cancer. It lacks the assessment of the "soil" signature of tumor microenvironment. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. This study is a retrospective observational study performed in two centers. The main purpose of this study was to investigate whether the tumor microenvironment collagen signature (CSTME) can discriminate the 5-year DFS of stage II/III CRC patients, the secondary purpose is to compare the AUC (area under the receiver operating characteristic curve) of TNM stage+CSTME in predicting 5-year DFS with that of TNM stage alone. This study would introduce the tumor microenvironmental collagen signature into current colorectal cancer classification system, which would provide reference for clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: May 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically diagnosed with colorectal cancer
• TNM stages II and III (according to the 8th edition of AJCC Cancer Staging Manual)
• Received radical tumor resection surgery

Exclusion Criteria:

• ASA grade 4
• Preoperative radiotherapy and/or chemotherapy
• Hereditary colorectal cancer
• Pregnancy

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• CSTME
Tumor microenvironment collagen signature

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year DFS	5-year disease free survival	5 years followup after surgery
Secondary	5-year OS	5-year overall survival	5 years followup after surgery