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

Recruiting

• Conditions: Colorectal Adenoma
• Interventions: Diagnostic Test: PrecogColo Dx test

• Registration Number: NCT05870696
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-30
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Primary Completion: 2024-02-27
• Study Completion: 2024-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Read More

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")

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
negative	PrecogColo Dx test	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
Positive	PrecogColo Dx test	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

Primary Outcome Measures

Name	Time	Method
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%.

Trial Locations

Locations (6)

Beijing Huaxin Hospital; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Aerospace Center Hospital; 🇨🇳 Beijing, Beijing, China

Peking university third hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Beijing haidian hospital; 🇨🇳 Beijing, Beijing, China