Chinese Colorectal Cancer Database

NCT05434026 | Recruiting

• 1 other identifier: CCCD
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Provide academic consultation and data support to national health authorities.

Conditions

Colonic Cancer; Rectal Cancer; Prospective Studies

Outcome Measures

Primary Outcomes (10)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zhongtao Zhang

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Zhongtao Zhang

CONTACT

13801060364; zhangzht@ccmu.edu.cn

Hongwei Yao

CONTACT

13611015609; yaohongwei@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general surgery, principal investigato

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: August 3, 2022
• Primary Completion (Estimated): June 22, 2032
• Study Completion (Estimated): June 22, 2032
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

CN (1)