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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05870696
Collaborator
(none)
2,000
Enrollment
6
Locations
10
Anticipated Duration (Months)
333.3
Patients Per Site
33.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PrecogColo Dx test

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 Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening
Actual Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Feb 27, 2024
Anticipated Study Completion Date :
Feb 27, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts 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:

  9. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)

  10. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Huaxin Hospital Beijing Beijing China 100016
2 Cancer Hospital Chinese Academy of Medical Science Beijing Beijing China 100021
3 China-Japan Friendship Hospital Beijing Beijing China 100029
4 Aerospace Center Hospital Beijing Beijing China 100049
5 Beijing haidian hospital Beijing Beijing China 100080
6 Peking university third hospital Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05870696
Other Study ID Numbers:
  • PekingUTH-ding36
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
colorectal adenomas; colorectal cancer
Additional relevant MeSH terms:
Adenoma

Study Results

No Results Posted as of May 23, 2023