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

Recruiting

• Conditions: Colorectal Cancer; Colorectal Adenoma
• Interventions: Diagnostic Test: Colonoscopy; Diagnostic Test: Test of ctDNA methylation; Diagnostic Test: Test of characteristics of ctDNA fragment

• Registration Number: NCT05587452
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24
• Primary Completion: 2023-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 950

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. 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;
2. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal cancer group	Test of characteristics of ctDNA fragment	People with colorectal cancer
Healthy group	Colonoscopy	People without colorectal adenoma or cancer
Advanced adenoma group	Test of characteristics of ctDNA fragment	People with colorectal adenoma
Colorectal cancer group	Test of ctDNA methylation	People with colorectal cancer
Healthy group	Test of ctDNA methylation	People without colorectal adenoma or cancer
Healthy group	Test of characteristics of ctDNA fragment	People without colorectal adenoma or cancer
Advanced adenoma group	Colonoscopy	People with colorectal adenoma
Advanced adenoma group	Test of ctDNA methylation	People with colorectal adenoma
Colorectal cancer group	Colonoscopy	People with colorectal cancer

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Heji Hospital affiliated to Changzhi Medical College; 🇨🇳 Changzhi, Shanxi, China

Affiliated Hospital of Weifang Medical University; 🇨🇳 Weifang, Shandong, China

Beiijing Fengtai Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Cangzhou Central Hospital; 🇨🇳 Cangzhou, Hebei, China