Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05528783

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

Led by Sun Yat-sen University · Updated on 2022-09-21

200

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

N

New Horizon Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathological diagnosis of colorectal adenocarcinoma
  • Age between 18 and 80 years, any gender
  • Undergoing radical surgery for colorectal cancer
  • No antitumor therapy before surgery (including chemotherapy, radiation, targeted therapy, or immunotherapy)
  • No distant metastasis detected before surgery
  • No severe hemorrhoids or other known conditions causing gastrointestinal bleeding before surgery
  • Complete clinical treatment data available
Not Eligible

You will not qualify if you...

  • History of digestive tract tumors other than colorectal cancer
  • Previous colorectal surgery
  • Requirement of a fistula
  • Complete intestinal obstruction or perforation
  • Pregnant or breastfeeding women
  • Metastases found during surgery that cannot be removed radically
  • Unwilling or unable to sign informed consent
  • Strict vegetarian diet
  • Unwilling or unable to follow up according to the protocol or poor follow-up compliance
  • Any condition deemed inappropriate for inclusion by the study physician

AI-Screening

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Trial Site Locations

Total: 1 location

1

Colorectal Department,SunYat-sen University Cancer Center

Guangzhou, Guangdong, China, 510062

Actively Recruiting

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Research Team

J

Junzhong Lin

CONTACT

Z

Zhizhong Pan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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