Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection

Study Overview
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Brief Summary
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Exploration of a novel rbcDNA liquid biopsy technique for early detection of colorectal cancer is a promising development in the field of disease diagnosis and screening. This technique has the potential to establish an efficient and sensitive system for the early detection of colorectal cancer, which can provide a new perspective for individual health monitoring.

Detailed Description
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Patients who are at high risk of developing colorectal cancer and willing to undergo colonoscopy examination will be asked to collect a stool sample prior to bowel preparation for commercially available FIT (fecal immunochemical test) assay, as well as a blood sample for rbcDNA testing. The colonoscopy and histopathologic examination will be used as a reference for the results obtained from these tests.

Official Title
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Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection

Conditions
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Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma

Intervention / Treatment
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* Diagnostic Test: rbcDNA test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:40-74Years Sex:All Willing to provide written consent Plan to undergo colorectaloscopy or surgical treatment and be able to provide a complete medical history and cooperate with blood sampling and follow-up visits，other operation. For advanced adenomas (AA) group: Adenomatous polyps with ≥25% villous component, high-grade dysplasia (HGD), or a diameter ≥10 mm were considered AA. Sessile serrated lesions with diameters ≥10 mm. treatment-naive No other comorbid tumors For CRC group: Confirmed CRC patients treatment-naive No other comorbid tumors Exclusion Criteria: Patients with colorectal cancer who have received prior treatment. FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis Participants taking anticoagulants such as aspirin or warfarin, or those with coagulation disorders. Prior history of colonoscopy within the past 5 years and removal of lesions Pregnancy or intestinal infarction people Unable to provide informed consent Participants in other clinical trials or who have participated in other clinical trials within 60 days. Unable to provide stool sample and follow-up visits. Presence of major infectious diseases (e.g. HIV, etc.)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| advanced adenomas (AA) group<br>Prospective enrollment of subjects with advanced adenomas | Diagnostic Test: rbcDNA test<br>* fecal immunochemical test<br>* Other names: FIT;|
| CRC group<br>Retrospective enrollment of subjects with confirmed colorectal cancer | Diagnostic Test: rbcDNA test<br>* fecal immunochemical test<br>* Other names: FIT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening | A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA test was deployed to a composite score. The tests were processed independently of colonoscopy procedure. | Through study completion，an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the rbcDNA screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC | A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA and FIT test were performed. | Through study completion，an average of 1 year |