Clinical trial NCT05420415: The CSTME Associates With the Prognosis of Stage II and III Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
First posted: 2022-06-15
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with stageII/III colorectal cancer

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.

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

Primary outcomes:
measure: 5-year DFS
timeFrame: 5 years followup after surgery
Secondary outcomes:
measure: 5-year OS
timeFrame: 5 years followup after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jun Yan, MD
role: STUDY_CHAIR
References: