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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05638243
Acronym
METHOD-3
Enrollment
10000
Registered
2022-12-06
Start date
2022-08-20
Completion date
2025-09-30
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Neoplasms

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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of subjects receiving colonoscopyThree yearsProportion of subjects receiving colonoscopy
Proportion of subjects suffering early colorectal cancerThree yearsProportion of stageⅠcancer in total colorectal cancer
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenomaThree yearsSensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

Countries

China

Contacts

Primary ContactDonghao Xu, M.D.
xdh1225@yeah.net+86 17621317456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026