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NCT Number: NCT05434026

Chinese Colorectal Cancer Database

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.

Recruiting

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Key information

Conditions

Colonic Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Prospective Studies Rectal Cancer Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Positive rate of circumferential resection margin (CRM) of the specimens

    Time frame: 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.

  2. The grade score of the specimens integrity

    Time frame: 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.

  3. The distance between lower tumor margin and the lower reaction margin

    Time frame: 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.

  4. local recurrence rate

    Time frame: 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.

  5. the operative time

    Time frame: 30 days after surgery

    preoperative safety containing operation information, complication information.

  6. postoperative hospital stay

    Time frame: 3 year after surgery

    recovery information.

  7. the score of postoperative life

    Time frame: 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.

  8. disease free survival rate

    Time frame: 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.

  9. overall survival rate

    Time frame: 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.

  10. the rate of postoperative complications

    Time frame: 30 days after surgery

    preoperative safety containing operation information, complication information.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongwei Yao

CONTACT

[email protected]

13611015609

Zhongtao Zhang

CONTACT

[email protected]

13801060364

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • 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

Registry information

Acronym: CCCD

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jun 27, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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