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Trial 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
NCT ID:
NCT05638243
Condition:
Colorectal Cancer
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
50 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Community Health Centers in Xuhui District
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Donghao Xu, M.D.
Phone:
+86 17621317456
Email:
xdh1225@yeah.net
Start date:
August 20, 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638243
