Chinese Colorectal Cancer Database

Recruiting

• Conditions: Prospective Studies; Colonic Cancer; Rectal Cancer

• Registration Number: NCT05434026
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Study Start: 2022-08-03
• Last Update Posted: 2022-08-03
• Primary Completion: 2032-06-22
• Study Completion: 2032-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local recurrence rate	3 years after surgery	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.
disease free survival rate	3-year after surgery	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.
the rate of postoperative complications	30 days after surgery	preoperative safety containing operation information, complication information.
Positive rate of circumferential resection margin (CRM) of the specimens	10 days after surgery	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.
The grade score of the specimens integrity	10 days after surgery	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.
The distance between lower tumor margin and the lower reaction margin	10 days after surgery	shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
postoperative hospital stay	3 year after surgery	recovery information.
the score of postoperative life	6 months after surgery	quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.
the operative time	30 days after surgery	preoperative safety containing operation information, complication information.
overall survival rate	3-year after surgery	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.

Trial Locations

Locations (1)

Zhongtao Zhang; 🇨🇳 Beijing, China