Early diagnosis of colorectal cancer using blood tests
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
This study is testing a new blood test to see if it can help find colorectal cancer earlier in people aged 50 to 75 who have already had a positive screening result.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05638243 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new method for early detection of colorectal cancer by analyzing 5-hydroxymethylcytosine (5-hmC) in plasma cell-free DNA. It targets individuals aged 50 to 75 who have shown positive results in initial colorectal cancer screening tests. The approach aims to improve screening compliance and efficiency in a community setting, particularly in Shanghai, where traditional methods have low participation rates. Participants will provide blood samples for analysis after signing informed consent.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 75 with positive initial screening results for colorectal cancer.
Not a fit: Patients with a history of colorectal cancer or adenomas will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly enhance early detection of colorectal cancer, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using DNA methylation for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai
- Community Health Centers in Xuhui District — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jianmin Xu, M.D.， PhD — Fudan University
- Study coordinator: Donghao Xu, M.D.
- Email: xdh1225@yeah.net
- Phone: +86 17621317456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.