Chinese Colorectal Cancer Database (CCCD)

1. To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
2. Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
3. Provide academic consultation and data support to national health authorities.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Colonic Cancer; Prospective Studies

• Study Type: Observational
• Enrollment (Anticipated): 200000

Contacts and Locations

• Study Contact: Name: Zhongtao Zhang; Phone Number: 13801060364; Email: zhangzht@ccmu.edu.cn
• Study Contact Backup: Name: Hongwei Yao; Phone Number: 13611015609; Email: yaohongwei@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Zhongtao Zhang
    • Contact: Yishan Liu; Phone Number: 13065025613; Email: LYSliuyishan613@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

colorectal cancer patients who are suitable and willing to accept the surgery and also agree with the trial

Description

Inclusion Criteria:

• adenocarcinoma of the colon by biopsy
• tolerable to surgery
• be able to understand and willing to participate in this trial with signature

Exclusion Criteria:

• can not tolerate the surgery
• history of serious mental illness
• the researchers believe the patients should not enrolled in

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of circumferential resection margin (CRM) of the specimens	Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.	10 days after surgery
The grade score of the specimens integrity	shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.	10 days after surgery
The distance between lower tumor margin and the lower reaction margin	shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.	10 days after surgery
local recurrence rate	show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.	3 years after surgery
the operative time	preoperative safety containing operation information, complication information.	30 days after surgery
postoperative hospital stay	recovery information.	3 year after surgery
the score of postoperative life	quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.	6 months after surgery
disease free survival rate	show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.	3-year after surgery
overall survival rate	show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.	3-year after surgery
the rate of postoperative complications	preoperative safety containing operation information, complication information.	30 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking University People's Hospital; Peking Union Medical College Hospital; Peking University Cancer Hospital & Institute; Ruijin Hospital; Beijing Chao Yang Hospital; The First Hospital of Jilin University; First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 3, 2022
• Primary Completion (Anticipated): June 22, 2032
• Study Completion (Anticipated): June 22, 2032

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 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: CCCD

Drug and device information, study documents

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