Colorectal Adenoma, Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Early screening, Multi-omics, ctDNA, Artifical intelligence
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTColonoscopy
Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer
DIAGNOSTIC_TESTTest of ctDNA methylation
A specified panel is used to detect the site of methylation of ctDNA in plasma
DIAGNOSTIC_TESTTest of characteristics of ctDNA fragment
Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment
Sponsors
Cangzhou Central Hospital
Weifang Medical University
Heji Hospital affiliated to Changzhi Medical College
Beijng Fengtai Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion criteria for colorectal cancer/advanced adenoma 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Be able to provide sufficient and qualified blood samples for this study 3) Patients with pathological diagnosis of colorectal cancer stage I-III (TNM staging according to AJCC 8th edition colorectal cancer staging system) 4) No previous cancer treatment, including chemotherapy, radiotherapy, targeted or immunotherapy, and any surgery treat 5) Advanced adenoma should at least meet one of the following conditions: ① Diameter \>10mm ② Villus-tubiform adenoma ③ More than 25% of villi structure in mixed adenoma ④High-grade intraepithelial neoplasia 2. Inclusion criteria for healthy people 1) Voluntarily participate and sign the informed consent form, and be able to cooperate with the entire research process 2) Diagnosed without colorectal adenoma or cancer by colonoscopy within 12 months
Exclusion criteria
1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Through study completion, an average of 1 year | 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. |
| Specificity | Through study completion, an average of 1 year | 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. |
Countries
China
Contacts
Primary ContactJianqiang Tang, Dr.
Backup ContactMingguang Zhang, Dr.
Outcome results
None listed