Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence
NCT ID: NCT05587452
Last Updated: 2022-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
950 participants
OBSERVATIONAL
2022-05-01
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy group
People without colorectal adenoma or cancer
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
Advanced adenoma group
People with colorectal adenoma
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
Colorectal cancer group
People with colorectal cancer
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
Interventions
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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
Eligibility Criteria
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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.
18 Years
75 Years
ALL
Yes
Sponsors
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Cangzhou Central Hospital
OTHER
Weifang Medical University
OTHER
Heji Hospital affiliated to Changzhi Medical College
UNKNOWN
Beijng Fengtai Hospital
UNKNOWN
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jianqiang Tang
Associate professor
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beiijing Fengtai Hospital
Beijing, Beijing Municipality, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
Heji Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Fucheng Liu, Dr.
Role: primary
Guiwei Liu, Dr.
Role: primary
Bin Ren, Dr.
Role: primary
Wei Guo, Dr.
Role: primary
Other Identifiers
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NCC3511
Identifier Type: -
Identifier Source: org_study_id
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