The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

Colon Cancer Clinical Trial

Official title:

The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03794193
• Other study ID #: ZS-1653
• Status: Active, not recruiting
• Start date: January 1, 2016
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1367
• Est. completion date: December 2023
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age: 18-100 years old;

2. Postoperative pathology confirmed colon adenocarcinoma;

3. The tumor is located from the cecum to the sigmoid colon;

4. No distant organ metastasis;

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;

2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)

3. local excision procedure;

4. palliative resection (R2 resection);

5. pregnant or lactating women.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• Radical resection of colon cancer
The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking University First Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, West China Hospital, Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3-year Over-all Survival	The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.	Within 3 years after surgery
Secondary	Postoperative complication rate		Within 30 days after surgery
Secondary	Postoperative mortality rate		Within 30 days after surgery
Secondary	Local recurrence rate		Within 3 years after surgery
Secondary	Distant organ metastasis rate		Within 3 years after surgery