the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening

Study Overview
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Brief Summary
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This study is to Evaluate the diagnostic sensitivity of the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer. There are two steps in this study. Firstly, the diagnostic model is established based on tumor-specific and gut-microbiome related serum metabolites. Secondly, the sensitivity, specificity and accuracy of the diagnostic model is evaluated in detecting advanced adenoma and colorectal cancer stages in an independent multi-centered cohort.

Detailed Description
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Subjects aged >45 at average risk for development of CRC will be enrolled. Subjects will complete the PrecogColo Dx test, followed by completion of a screening colonoscopy. . Results from PrecogColo Dx test were compared to the results of an optical colonoscopic examination, and histopathological diagnosis of all significant lesions discovered during the colonoscopy, in order to determine the sensitivity for CRC and advanced adenoma, respectively, as well as determining specificity of non-advanced neoplasia individuals. Histopathological results from biopsied tissue or excised lesions were categorized based on the most clinically significant lesion present by a central pathologist.

Official Title
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Evaluation of the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening

Conditions
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Colorectal Adenoma

Intervention / Treatment
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* Diagnostic Test: PrecogColo Dx test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 45 years of age at the time of enrollment. Subject presents for a screening colonoscopy. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. Subject is able and willing to sign informed consent. Exclusion Criteria: Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and targeted therapy. Patients received antibiotics within 2 weeks. Patients with indications of emergency surgery, including bleeding, obstruction and perforation. Patients who are positive for Human Immunodeficiency Virus (HIV). Patients with abnormal liver and kidney function. Patients with the history of inflammatory bowel disease. Patients who had history of other malignancies. Subject has a diagnosis or medical history of any of the following conditions: Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP and Gardner's syndrome) Hereditary non-polyposis CRC syndrome (also referred to as HNPCC or Lynch Syndrome)

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| negative<br>normal:no findings on colonoscopy hyperplastic polyps: inflammatory or hyperplastic polyps low-risk adenoma:1 or 2 adenoma(s), ≤10 mm in size, non-advanced | Diagnostic Test: PrecogColo Dx test<br>* the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer<br>|
| Positive<br>advanced adenoma Advance adenoma, including the following subcategories: Adenoma with carcinoma in situ/high grade dysplasia, any size Adenoma, villous growth pattern (>25%), any size Adenoma > 1.0 cm in size Serrated lesion, > 1.0 cm in size early stage CRC: CRC stage I advanced stage CRC: CRC stage II-IV | Diagnostic Test: PrecogColo Dx test<br>* the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Evaluations | Lower bound of the 95% one-sided confidence interval of PrecogColo Dx Sensitivity for CRC was greater than 65%, and lower bound of the 95% one-sided confidence interval of PrecogColo Dx specificity for non-advanced neoplasia (including normal, non-adenomas polyps and low risk adenoma) was greater than 85%. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal adenomas; colorectal cancer