Clinical trial NCT05638243: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Neoplasms
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Xuhui District, Shanghai, who are initially screened as high-risk for colorectal cancer by Shanghai Xuhui District Center for Disease Control and Prevention, and do not receive a colonoscopy. People who are willing to accept the screening program.

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.


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.

Primary outcomes:
measure: Proportion of subjects receiving colonoscopy
timeFrame: Three years
measure: Proportion of subjects suffering early colorectal cancer
timeFrame: Three years
measure: Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Community Health Centers in Xuhui District
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu, M.D.， PhD
role: PRINCIPAL_INVESTIGATOR
References: