Clinical trial · Observational
the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening
Evaluation of the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening
NCT05870696CI-TRIAL-00066601unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PrecogColo Dx test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- negative
- description
- 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
- interventionNames
- Diagnostic Test: PrecogColo Dx test
- label
- Positive
- description
- 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
- interventionNames
- Diagnostic Test: PrecogColo Dx test
Primary outcomes (1)
- measure
- Primary Effectiveness Evaluations
- timeFrame
- 2 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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")
References
Publications (7)
- BACKGROUNDBray 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
- BACKGROUNDVatandoost 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
- BACKGROUNDDoubeni 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
- BACKGROUNDNiedermaier 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
- BACKGROUNDJanney 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
- BACKGROUNDYachida 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.