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

Colorectal Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587452
• Other study ID #: NCC3511
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: October 2022
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jianqiang Tang, Dr.
• Phone: +8613661090036
• Email: doc_tjq[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ? Diameter >10mm ? Villus-tubiform adenoma ? More than 25% of villi structure in mixed adenoma ?High-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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Colonoscopy
Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer
• Test of ctDNA methylation
A specified panel is used to detect the site of methylation of ctDNA in plasma
• Test of characteristics of ctDNA fragment
Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment

Locations

Country	Name	City	State
China	Beiijing Fengtai Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Heji Hospital affiliated to Changzhi Medical College	Changzhi	Shanxi
China	Affiliated Hospital of Weifang Medical University	Weifang	Shandong

Sponsors (5)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijng Fengtai Hospital, Cangzhou Central Hospital, Heji Hospital affiliated to Changzhi Medical College, Weifang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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