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

Colorectal Cancer Clinical Trial

— METHOD-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638243
• Other study ID #: METHOD-3
• Status: Recruiting
• Start date: August 20, 2022
• Est. completion date: September 2025

Study information

• Verified date: November 2022
• Source: Fudan University
• Contact: Donghao Xu, M.D.
• Phone: +86 17621317456
• Email: xdh1225[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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); ? Receive sample collection; ? Sign the informed consent form. Exclusion Criteria: ? History of colorectal cancer, colorectal adenoma, and treatment;
• Enteroscopy was performed after the initial screening was positive; ? The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Community Health Centers in Xuhui District	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects receiving colonoscopy	Proportion of subjects receiving colonoscopy	Three years
Primary	Proportion of subjects suffering early colorectal cancer	Proportion of stage?cancer in total colorectal cancer	Three years
Primary	Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma	Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma	Three years