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

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: CSTME

• Registration Number: NCT05420415
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2021-09-01
• Status Verified: 2022-04
• Study Completion: 2022-05-01
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-12
• Last Update Submitted: 2022-06-12
• Study First Posted: 2022-06-15
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-CSTME	CSTME	Patients with high tumor microenvironment collagen signature

Primary Outcome Measures

Name	Time	Method
5-year DFS	5 years followup after surgery	5-year disease free survival

Secondary Outcome Measures

Name	Time	Method
5-year OS	5 years followup after surgery	5-year overall survival

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China