Colorectal Department,SunYat-sen University Cancer Center
Guangzhou, Guangdong, 510062, China
Location status: Recruiting
NCT Number: NCT05528783
Colorectal cancer (CRC) is a common cancer that threatens human health, with the incidence ranking the third in the world. 70% of patients are in the middle and late stages whendiagnosed, and even after radical surgery, 30% - 50% of patients with CRC have recurrence or metastasis after radical surgery. Therefore, after radical surgery and adjuvant chemotherapy, regular monitoring of CRC patients should be paid attention to in order to detect the recurrence and metastasis lesions that can be resected and the early non-invasive metachronous multiple primary tumors.
The sensitivity of FIT-DNA to CRC was 95.5%, the sensitivity to advanced adenoma (AA) was 63.5%, and the specificity was 87.5%, showing a good ability to screen colorectal cancer and precancerous lesions.
At present, there is no report on the application of FIT-DNA combined detection technology in the high-risk recurrence period and mid - and long-term monitoring after CRC surgery in China. In this study, Fit-DNA combined detection technology was applied to the follow-up monitoring of patients after CRC surgery, so as to optimize the current typical postoperative follow-up strategy, find early recurrence and multiple primary colorectal tumors after CRC surgery, seek the best postoperative follow-up model, improve the compliance of patients to follow-up, and ultimately benefit survival.
Detailed Description:Outline:This study was a single-center, observational study. Fit-DNA detection technology was used as a target method, and colonoscopy was used as the gold standard control to follow up and monitor patients with colorectal tumors after surgery, and to explore whether it is an effective non-invasive auxiliary method for monitoring CRC recurrence and metastasis and multiple primary colorectal tumors.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Guangzhou, Guangdong, 510062, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exit or terminate criteria:
Time frame: up to 5 years
The diagnostic sensitivity and specificity of FIT-DNA detection for local recurrence and advanced colorectal neoplasm of CRC.
Time frame: up to 5 years
1.The AUC of FIT-DNA in recurrent CRC and advanced colorectal stage.
Time frame: up to 5 years
2.NPV、PPVof FIT-DNA in recurrent CRC and advanced colorectal stage.
Time frame: up to 5 years
3.The time interval between CRC recurrence and advanced colorectal neogenesis after the first positive appearance was detected by FIT-DNA detection.
Contact information is provided by the study sponsor or research team.
Junzhong Lin
CONTACT
Zhizhong Pan
CONTACT
Sun Yat-sen University
Other
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