The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer
1 other identifier
observational
1,367
0 countries
N/A
Brief Summary
To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 4, 2022
April 1, 2022
4.9 years
September 9, 2018
April 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
3-year Disease-free Survival
The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.
Within 3 years after surgery
Secondary Outcomes (5)
3-year Over-all Survival
Within 3 years after surgery
Postoperative complication rate
Within 30 days after surgery
Postoperative mortality rate
Within 30 days after surgery
Local recurrence rate
Within 3 years after surgery
Distant organ metastasis rate
Within 3 years after surgery
Interventions
The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.
Eligibility Criteria
Colon cancer patients with or without unfavorable histological features
You may qualify if:
- Age: 18-100 years old;
- Postoperative pathology confirmed colon adenocarcinoma;
- The tumor is located from the cecum to the sigmoid colon;
- No distant organ metastasis;
You may not qualify if:
- Simultaneous or metachronous multiple primary colorectal cancer;
- History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
- local excision procedure;
- palliative resection (R2 resection);
- pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Chinese Academy of Medical Sciencescollaborator
- West China Hospitalcollaborator
- Sixth Affiliated Hospital, Sun Yat-sen Universitycollaborator
- Peking University First Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
Related Publications (1)
Li K, Zhao F, Guo Y, Wu Q, Luo S, Zhang J, Li H, Hu S, Wu B, Lin G, Qiu H, Niu B, Sun X, Xu L, Lu J, Du X, Wang Z, Wang X, Kang L, Wang Z, Wang Q, Liu Q, Xiao Y. Interaction analysis of high-risk pathological features on adjuvant chemotherapy survival benefit in stage II colon cancer patients: a multi-center, retrospective study. BMC Cancer. 2023 Sep 18;23(1):797. doi: 10.1186/s12885-023-11196-4.
PMID: 37718392DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Xiao, MD
Peking Union Medical College Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2018
First Posted
January 4, 2019
Study Start
January 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2023
Last Updated
May 4, 2022
Record last verified: 2022-04