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Clinical Trials/NCT05638243
NCT05638243
Recruiting
Not Applicable

Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program in Xuhui District, Shanghai

Fudan University1 site in 1 country10,000 target enrollmentAugust 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Fudan University
Enrollment
10000
Locations
1
Primary Endpoint
Proportion of subjects receiving colonoscopy
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%.

This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.

Registry
clinicaltrials.gov
Start Date
August 20, 2022
End Date
September 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xu jianmin

Director of Colorectal Surgery

Fudan University

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 50 years old and\<75 years old;
  • The initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive); ③ Receive sample collection; ④ Sign the informed consent form.

Exclusion Criteria

  • ① History of colorectal cancer, colorectal adenoma, and treatment;
  • Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.

Outcomes

Primary Outcomes

Proportion of subjects receiving colonoscopy

Time Frame: Three years

Proportion of subjects receiving colonoscopy

Proportion of subjects suffering early colorectal cancer

Time Frame: Three years

Proportion of stageⅠcancer in total colorectal cancer

Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

Time Frame: Three years

Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

Study Sites (1)

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