The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: Radical resection of colon cancer

• Study Type: Observational
• Enrollment (Anticipated): 1367

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Colon cancer patients with or without unfavorable histological features

Description

Inclusion Criteria:

1. Age: 18-100 years old;
2. Postoperative pathology confirmed colon adenocarcinoma;
3. The tumor is located from the cecum to the sigmoid colon;
4. No distant organ metastasis;

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
3. local excision procedure;
4. palliative resection (R2 resection);
5. pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year Disease-free Survival	The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.	Within 3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year Over-all Survival	The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.	Within 3 years after surgery
Postoperative complication rate		Within 30 days after surgery
Postoperative mortality rate		Within 30 days after surgery
Local recurrence rate		Within 3 years after surgery
Distant organ metastasis rate		Within 3 years after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Peking University First Hospital; West China Hospital; Sixth Affiliated Hospital, Sun Yat-sen University; Wuhan Union Hospital, China; National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Investigators: Principal Investigator: Yi XIAO, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 9, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: ZS-1653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Individual participant data can be shared with all researchers involved in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No