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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Adenoma
• Intervention / Treatment: Diagnostic test: Colonoscopy; Diagnostic test: Test of ctDNA methylation; Diagnostic test: Test of characteristics of ctDNA fragment

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 Type: Observational
• Enrollment (Anticipated): 950

Contacts and Locations

• Study Contact: Name: Jianqiang Tang, Dr.; Phone Number: +8613661090036; Email: doc_tjq@hotmail.com
• Study Contact Backup: Name: Mingguang Zhang, Dr.; Phone Number: +8613261967603; Email: zmgslimshady@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Jianqiang Tang, Dr.; Phone Number: +8613661090026; Email: doc_tjq@hotmail.com
      • Principal Investigator: Jianqiang Tang, Dr.
    • Beijing, Beijing, China
      • Recruiting
      • Beiijing Fengtai Hospital
      • Contact: Fucheng Liu, Dr.
  • Hebei
    • Cangzhou, Hebei, China
      • Recruiting
      • Cangzhou Central Hospital
      • Contact: Guiwei Liu, Dr.; Phone Number: +8618031792096
  • Shandong
    • Weifang, Shandong, China
      • Recruiting
      • Affiliated Hospital of Weifang Medical University
      • Contact: Bin Ren, Dr.; Phone Number: +8613563610520
  • Shanxi
    • Changzhi, Shanxi, China
      • Recruiting
      • Heji Hospital Affiliated to Changzhi Medical College
      • Contact: Wei Guo, Dr.; Phone Number: +8613835513617

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heathy group: Patients without colorectal adenoma or cancer examined by colonoscopy Precancerous group: Patients 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 Colorectal cancer group: Patients diagnosed with adenocarcinoma by colonoscopy and histological examination.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Cangzhou Central Hospital; Weifang Medical University; Heji Hospital affiliated to Changzhi Medical College; Beijng Fengtai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal cancer; ctDNA; Early screening; Multi-omics; Artifical intelligence
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: NCC3511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No