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

Colorectal Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870696
• Other study ID #: PekingUTH-ding36
• Status: Recruiting
• Start date: April 30, 2023
• Est. completion date: February 27, 2024

Study information

• Verified date: April 2023
• Source: Peking University Third Hospital
• Contact: shigang ding, doctor
• Phone: 15611908241
• Email: dingshigang222[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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")

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Intervention

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

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing	Beijing
China	Beijing haidian hospital	Beijing	Beijing
China	Beijing Huaxin Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking university third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & 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. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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