Chinese Colorectal Cancer Database

Rectal Cancer Clinical Trial

— CCCD  

Official title:

Chinese Colorectal Cancer Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434026
• Other study ID #: CCCD
• Status: Recruiting
• Start date: August 3, 2022
• Est. completion date: June 22, 2032

Study information

• Verified date: August 2022
• Source: Beijing Friendship Hospital
• Contact: Zhongtao Zhang
• Phone: 13801060364
• Email: zhangzht[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: June 22, 2032
• Est. primary completion date: June 22, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms
• Prospective Studies
• Rectal Cancer

Locations

Country	Name	City	State
China	Zhongtao Zhang	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Chao Yang Hospital, First Hospital of China Medical University, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Peking University People's Hospital, Ruijin Hospital, The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	the operative time	preoperative safety containing operation information, complication information.	30 days after surgery
Primary	postoperative hospital stay	recovery information.	3 year after surgery
Primary	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
Primary	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
Primary	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
Primary	the rate of postoperative complications	preoperative safety containing operation information, complication information.	30 days after surgery