Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence-a Multi-center, Prospective Study

Conditions
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Colorectal Adenoma, Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Colonoscopy
* Diagnostic Test: Test of ctDNA methylation
* Diagnostic Test: Test of characteristics of ctDNA fragment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: Exclusion criteria for colorectal cancer/advanced adenoma 1) Women who are pregnant or breastfeeding 2) Currently diagnosed with another cancer or have a history cancer 3) Persistent fever or receiving anti-inflammatory treatment within 14 days before blood samples are taken in this study 4) Receiving blood transfusion within 30 days 5) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 6) Digestive tract bleeding, obstruction, perforation and any trauma or surgery within 3 months 7) Poor physical condition, not suitable for extraction blood samples 8) Subjects who are judged by the investigator to be unsuitable to participate in this study for other reasons; Exclusion criteria for healthy people 1) Women who are pregnant or breastfeeding 2) Receiving organ transplantation or previous non-autologous (allogeneic) bone marrow or stem cell transplantation 3) Have a history cancer 4) Receiving blood transfusion within 30 days 5) Poor physical condition, not suitable for extraction Blood samples 6) Diagnosed with precancerous lesions by colonoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy group<br>People without colorectal adenoma or cancer | Diagnostic Test: Colonoscopy<br>* Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer<br>Diagnostic Test: Test of ctDNA methylation<br>* A specified panel is used to detect the site of methylation of ctDNA in plasma<br>Diagnostic Test: Test of characteristics of ctDNA fragment<br>* Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment<br>|
| Advanced adenoma group<br>People with colorectal adenoma | Diagnostic Test: Colonoscopy<br>* Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer<br>Diagnostic Test: Test of ctDNA methylation<br>* A specified panel is used to detect the site of methylation of ctDNA in plasma<br>Diagnostic Test: Test of characteristics of ctDNA fragment<br>* Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment<br>|
| Colorectal cancer group<br>People with colorectal cancer | Diagnostic Test: Colonoscopy<br>* Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer<br>Diagnostic Test: Test of ctDNA methylation<br>* A specified panel is used to detect the site of methylation of ctDNA in plasma<br>Diagnostic Test: Test of characteristics of ctDNA fragment<br>* Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Early screening, Multi-omics, ctDNA, Artifical intelligence