To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas.
Minimally invasive detection of circulating tumor DNA (ctDNA) in peripheral blood of patients with colorectal malignancies via liquid biopsy has emerged as a promising biomarker. This is urgently needed, as conventional imaging and plasma protein-derived biomarkers lack sensitivity and specificity.The goal of this observational study is to evaluate the effectiveness and accuracy of a novel screening method based on plasma multi-omics combining with artificial intelligence in five hospitals around China for the detection of colorectal cancer and advanced adenomas.
Study Type
OBSERVATIONAL
Enrollment
950
Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer
A specified panel is used to detect the site of methylation of ctDNA in plasma
Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeiijing Fengtai Hospital
Beijing, Beijing Municipality, China
RECRUITINGCangzhou Central Hospital
Cangzhou, Hebei, China
Sensitivity
Sensitivity (for colorectal cancer and\\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.
Time frame: Through study completion, an average of 1 year
Specificity
Specificity (for colorectal cancer and\\or advanced precancerous neoplasm) of this plasm-based multi-omics test. The diagnostic colonoscopy procedure is reference method. Lesions will be confirmed as malignancy or precancerous by pathological biopsy.
Time frame: Through study completion, an average of 1 year
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Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
RECRUITINGHeji Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, China
RECRUITING