Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC

Study Overview
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Brief Summary
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Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.

Official Title
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Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of Colorectal Cancer

Conditions
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Colorectal Cancer, Precancerous Lesion, Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose age is between 18-75. Patients who have signed informed consent form. Exclusion Criteria: Patients who have undergone colonic resection or polypectomy. Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days. Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis). Patients with pregnancy, severe chronic cardiopulmonary and renal disease. Patients with failed cecal intubation. Patients with poor BPQ necessitated a second bowel preparation. Patients refusing to participate or to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Control<br>Volunteers with no significant abnormalities on colonoscopy were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Non-advanced adenoma<br>Patients with non-advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Advanced adenoma<br>Patients with advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Inflammatory bowel disease<br>Patients with inflammatory bowel disease were given informed consent to obtain colon tissue biopsies and fecal specimens. | |
| Colorectal cancer<br>Patients with colorectal cancer were given informed consent to obtain cancer tissue biopsies and fecal specimens. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of advanced colorectal adenoma | An advanced colorectal adenoma is defined as a colorectal adenoma ≥10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of colorectal cancer | Lesions will be confirmed as malignant by histopathologic examination. | Through study completion, an average of 1 year | 
| Detection of non-advanced colorectal adenoma | A non-advanced colorectal adenoma is defined as tubular adenoma less than 1cm in diameter. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi-omics study, adenoma, Inflammatory Bowel Disease