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

May 12, 2023 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Science
        • Contact:
          • wei pei, doctor
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • shiyu du, doctor
          • Phone Number: 13911531937
      • Beijing, Beijing, China, 100080
        • Recruiting
        • Beijing Haidian Hospital
        • Contact:
          • yinyan guo, doctor
      • Beijing, Beijing, China, 100049
        • Recruiting
        • Aerospace Center Hospital
        • Contact:
          • yuanmin zhu, doctor
          • Phone Number: 13811634389
      • Beijing, Beijing, China, 100016
        • Recruiting
        • Beijing Huaxin Hospital
        • Contact:
          • yanli cheng, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects 45 years of age and older who are eligible for colorectal cancer screening and scheduled for a screening colonoscopy. Approximately 2,000 subjects will be targeted for enrollment.

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
negative
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
the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer
Positive

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
the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Evaluations
Time Frame: 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%.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: shigang ding, doctor, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Anticipated)

February 27, 2024

Study Completion (Anticipated)

February 27, 2024

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUTH-ding36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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