Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT06115837
• Collaborator: (none)
• Enrollment: 172
• Location: 1
• Actual Duration (Days): 25
• Patients Per Site Per Month: 209.4

Study Details

Study Description

Brief Summary

The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Procedure: multivisceral resection

Detailed Description

Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (MVR), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. In this study, investigators attempted to evaluate the prognostic factors of pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pT4bN0M0 patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 172 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection: A Multi-institutional Retrospective Analysis
• Actual Study Start Date: Sep 1, 2023
• Actual Primary Completion Date: Sep 16, 2023
• Actual Study Completion Date: Sep 26, 2023

Outcome Measures

Primary Outcome Measures

1. Overall survival [The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.]

   Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.

2. Cancer specific survival [The endpoint of the cancer specific survival assessment is the patient death due to cancer. Follow-up time is up to 72 months.]

   Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The patient was pathologically diagnosed as colorectal adenocarcinoma.

2. Patients with pT4bN0M0 colorectal cancer.

3. Patients with R0 resection.

Exclusion Criteria:

1. Patients with distant metastasis.

2. Patients with R1 or R2 resection.

3. Patients with lymph node metastasis

4. Recurrent colorectal cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital Chinese Academy of Medical Sciences	Beijing		China	100021

Sponsors and Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT06115837
• Other Study ID Numbers: NCC2330
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences: Colorectal Cancer; Multivisceral resection; Prognosis
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Nov 3, 2023