Trial Title:
Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence
NCT ID:
NCT05587452
Condition:
Colorectal Adenoma
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Adenoma
Conditions: Keywords:
Colorectal cancer
Early screening
Multi-omics
ctDNA
Artifical intelligence
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Colonoscopy
Description:
Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer
Arm group label:
Advanced adenoma group
Arm group label:
Colorectal cancer group
Arm group label:
Healthy group
Intervention type:
Diagnostic Test
Intervention name:
Test of ctDNA methylation
Description:
A specified panel is used to detect the site of methylation of ctDNA in plasma
Arm group label:
Advanced adenoma group
Arm group label:
Colorectal cancer group
Arm group label:
Healthy group
Intervention type:
Diagnostic Test
Intervention name:
Test of characteristics of ctDNA fragment
Description:
Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment
Arm group label:
Advanced adenoma group
Arm group label:
Colorectal cancer group
Arm group label:
Healthy group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianqiang Tang, Dr.
Phone:
+8613661090026
Email:
doc_tjq@hotmail.com
Investigator:
Last name:
Jianqiang Tang, Dr.
Email:
Principal Investigator
Facility:
Name:
Beiijing Fengtai Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Fucheng Liu, Dr.
Facility:
Name:
Cangzhou Central Hospital
Address:
City:
Cangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Guiwei Liu, Dr.
Phone:
+8618031792096
Facility:
Name:
Affiliated Hospital of Weifang Medical University
Address:
City:
Weifang
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Ren, Dr.
Phone:
+8613563610520
Facility:
Name:
Heji Hospital affiliated to Changzhi Medical College
Address:
City:
Changzhi
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Guo, Dr.
Phone:
+8613835513617
Start date:
May 1, 2022
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Cangzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Weifang Medical University
Agency class:
Other
Collaborator:
Agency:
Heji Hospital affiliated to Changzhi Medical College
Agency class:
Other
Collaborator:
Agency:
Beijng Fengtai Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05587452
