Colorectal Adenoma
Conditions
Keywords
colorectal adenomas; colorectal cancer
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTPrecogColo Dx test
the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 45 years of age at the time of enrollment. 2. Subject presents for a screening colonoscopy. 3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. 4. Subject is able and willing to sign informed consent.
Exclusion criteria
1. Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and targeted therapy. 2. Patients received antibiotics within 2 weeks. 3. Patients with indications of emergency surgery, including bleeding, obstruction and perforation. 4. Patients who are positive for Human Immunodeficiency Virus (HIV). 5. Patients with abnormal liver and kidney function. 6. Patients with the history of inflammatory bowel disease. 7. Patients who had history of other malignancies. 8. Subject has a diagnosis or medical history of any of the following conditions: 1. Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP and Gardner's syndrome) 2. Hereditary non-polyposis CRC syndrome (also referred to as HNPCC or Lynch Syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Evaluations | 2 weeks | 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%. |
Countries
China
Contacts
Primary Contactshigang ding, doctor
Outcome results
None listed