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Research on Intelligent Screening and Follow up Management of Colorectal Cancer Based on Blood ctDNA Multi gene Methylation Technology and Machine Learning

Research on Intelligent Screening and Follow up Management of Colorectal Cancer Based on Blood ctDNA Multi gene Methylation Technology and Machine Learning

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086261
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-03-19
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Screening group for high-risk groups of colorectal cancer:None
Colorectal cancer postoperative group(Stages ?-?):None

Sponsors

The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Screening group inclusion criteria (a) Age range from 50 to 74 years old, regardless of gender; Agree to provide timely feedback on tumor related results in the health examination report to the researchers; (b) At least one of the following situations must be met: i. First degree relatives with a history of colorectal cancer; ii. Have a history of intestinal polyps or adenomas; iii. Inflammatory bowel disease (including ulcerative colitis and Crohn's disease) that has not healed for more than 8 years; iv. Fecal occult blood test positive. (c) Having full capacity for civil conduct; (d) Agree to promptly provide feedback to the researchers on information related to tumor diagnosis during external hospital visits during the research process; (e) Willing and able to sign an informed consent form. Postoperative inclusion criteria (a) Histopathologically confirmed colorectal cancer with imaging stage I-III; (b) At least 18 years of age, regardless of gender; (c) To undergo radical resection; (d) ECOG score =1; (e) Enrolled patients were newly diagnosed and did not receive surgery, radiotherapy, chemotherapy, targeted therapy, or other tumor-related interventions; (f) Complete medical records; (g) Those who understand and voluntarily sign the informed consent, subjects whose compliance is determined by the investigator.

Exclusion criteria

Exclusion criteria: Screening group exclusion criteria (a) Previous history of malignant tumor; (b) Is receiving any cancer-related treatment; (c) Those who have received major surgical treatments such as blood transfusions or transplants within three months; (d) Participate in other interventional clinical investigators within 3 months; (e) Those with autoimmune diseases, genetic diseases, mental disorders/disabilities, etc. that the investigator deems unsuitable for participation in the study; (f) Poor compliance, judged by the researcher to be unable to complete the study. Exclusion criteria for postoperative group (a) MSI-H or dMMR; (b) Non-primary bowel cancer; (c) Had a blood transfusion during or within 2 weeks prior to surgery; (d) With other intestinal malignancies; (e) Pregnant or lactating women; (f) Preoperative neoadjuvant radiotherapy/chemotherapy; (g) Failure to follow up the trial plan on time; (h) The sample quality does not meet the test requirements.

Design outcomes

Primary

MeasureTime frame
circulating tumor DNA (ctDNA) methylation;

Secondary

MeasureTime frame
Carcinoembryonic antigen (CEA);

Countries

China

Contacts

Public ContactXiaomin Dong

The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

517026730@qq.com+86 187 0986 7396

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026