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Clinical Trials/NCT05420415
NCT05420415
Completed
Not Applicable

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

Nanfang Hospital, Southern Medical University1 site in 1 country570 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
570
Locations
1
Primary Endpoint
5-year DFS
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
May 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

5-year DFS

Time Frame: 5 years followup after surgery

5-year disease free survival

Secondary Outcomes

  • 5-year OS(5 years followup after surgery)

Study Sites (1)

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