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

NCT05870696 | Unknown

• 1 other identifier: PekingUTH-ding36
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Adenoma

Keywords

colorectal adenomas; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

PrecogColo Dx test DIAGNOSTIC_TEST

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

Positive; negative

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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")

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (6)

Beijing Huaxin Hospital

Beijing, Beijing Municipality, 100016, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

RECRUITING

Beijing haidian hospital

Beijing, Beijing Municipality, 100080, China

RECRUITING

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (7)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Vatandoost N, Ghanbari J, Mojaver M, Avan A, Ghayour-Mobarhan M, Nedaeinia R, Salehi R. Early detection of colorectal cancer: from conventional methods to novel biomarkers. J Cancer Res Clin Oncol. 2016 Feb;142(2):341-51. doi: 10.1007/s00432-015-1928-z. Epub 2015 Feb 17.

  PMID: 25687380 BACKGROUND

• Doubeni CA, Corley DA, Quinn VP, Jensen CD, Zauber AG, Goodman M, Johnson JR, Mehta SJ, Becerra TA, Zhao WK, Schottinger J, Doria-Rose VP, Levin TR, Weiss NS, Fletcher RH. Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study. Gut. 2018 Feb;67(2):291-298. doi: 10.1136/gutjnl-2016-312712. Epub 2016 Oct 12.

  PMID: 27733426 BACKGROUND

• Niedermaier T, Balavarca Y, Brenner H. Stage-Specific Sensitivity of Fecal Immunochemical Tests for Detecting Colorectal Cancer: Systematic Review and Meta-Analysis. Am J Gastroenterol. 2020 Jan;115(1):56-69. doi: 10.14309/ajg.0000000000000465.

  PMID: 31850933 BACKGROUND

• Janney A, Powrie F, Mann EH. Host-microbiota maladaptation in colorectal cancer. Nature. 2020 Sep;585(7826):509-517. doi: 10.1038/s41586-020-2729-3. Epub 2020 Sep 23.

  PMID: 32968260 BACKGROUND

• Yachida S, Mizutani S, Shiroma H, Shiba S, Nakajima T, Sakamoto T, Watanabe H, Masuda K, Nishimoto Y, Kubo M, Hosoda F, Rokutan H, Matsumoto M, Takamaru H, Yamada M, Matsuda T, Iwasaki M, Yamaji T, Yachida T, Soga T, Kurokawa K, Toyoda A, Ogura Y, Hayashi T, Hatakeyama M, Nakagama H, Saito Y, Fukuda S, Shibata T, Yamada T. Metagenomic and metabolomic analyses reveal distinct stage-specific phenotypes of the gut microbiota in colorectal cancer. Nat Med. 2019 Jun;25(6):968-976. doi: 10.1038/s41591-019-0458-7. Epub 2019 Jun 6.

  PMID: 31171880 BACKGROUND

• Chen F, Dai X, Zhou CC, Li KX, Zhang YJ, Lou XY, Zhu YM, Sun YL, Peng BX, Cui W. Integrated analysis of the faecal metagenome and serum metabolome reveals the role of gut microbiome-associated metabolites in the detection of colorectal cancer and adenoma. Gut. 2022 Jul;71(7):1315-1325. doi: 10.1136/gutjnl-2020-323476. Epub 2021 Aug 30.

  PMID: 34462336 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• shigang ding, doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shigang ding, doctor

CONTACT

15611908241; dingshigang222@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: April 30, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-04

Locations

CN (6)