RecruitingNCT05528783

Application of FIT-DNA Detection in Following Colorectal Cancer Resection-Implications for Surveillance


Sponsor

Sun Yat-sen University

Enrollment

200 participants

Start Date

Apr 25, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a stool-based DNA test (FIT-DNA) can detect signs of colorectal cancer returning after surgery, potentially serving as a useful tool for long-term monitoring. **You may be eligible if...** - You are 18–80 years old with a confirmed colorectal adenocarcinoma - You have undergone or are scheduled for a curative (complete) surgical removal of your colon or rectal cancer - You have not received any cancer treatment (chemo, radiation, immunotherapy) before surgery - Your cancer had not visibly spread to other organs before surgery - You have no known serious gastrointestinal bleeding conditions other than cancer **You may NOT be eligible if...** - You have had other digestive tract cancers in the past - You have had previous colorectal surgery - You need a permanent stoma (bowel diversion) - You had a completely blocked or perforated bowel - You are pregnant or breastfeeding - You follow a strict vegetarian diet (which affects the test results) - You are unwilling to follow up per the study schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Colorectal Department,SunYat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05528783


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