Clinical trial · Observational
Comparison of Diagnostic Sensitivity Between ctDNA Methylation and CEA in Colorectal Cancer
Comparison of Diagnostic Sensitivity Between Circulating Tumor DNA Methylation and Carcinoembryonic Antigen in Colorectal Cancer
NCT05558436CI-TRIAL-00077044unknownClinicalTrials.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 is a prospective diagnostic study. This study is to compare the performance between circulating tumor DNA (ctDNA) methylation and carcinoembryonic antigen (CEA) in detecting colorectal tumor. Firstly, based on the identification of differential ctDNA methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of CEA. Secondly, the stage stratification model was established preliminarily based on differential ctDNA methylation biomarkers and the performance was also compared with that of CEA.
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 Tumor | Colorectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genome-wide methylation profiling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case group
- description
- Patients with colorectal cancer and advanced adenoma.
- interventionNames
- Diagnostic Test: Genome-wide methylation profiling
- label
- Control group
- description
- Healthy participants and patients with benign colorectal disease.
- interventionNames
- Diagnostic Test: Genome-wide methylation profiling
Primary outcomes (1)
- measure
- Diagnostic sensitivity
- timeFrame
- 3 years
- description
- The comparison of sensitivity between ctDNA methylation and CEA in detecting colorectal cancer
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Case group * Patients must have histologically confirmed colorectal cancer or advanced adenoma. * Patients need to receive surgical resection or endoscopic resection. * Patients have a performance status of ≤1 on the ECOG Performance Scale. * Written informed consent must be obtained. Control group * Written informed consent must be obtained. * Individuals must receive colonoscopy. Exclusion Criteria: * Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemoradiotherapy and targeted therapy. * Patients received antibiotics regularly. * Patients received blood transfusion two weeks before the drawn of blood sample. * 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 other malignancies, inflammatory bowel disease and Lynch syndrome. * Patients who are pregnant or breastfeeding. * Alcoholic or drug abusers.
References
Publications (12)
- BACKGROUNDSiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. PMID 33433946
- BACKGROUNDSchilsky RL, Nass S, Le Beau MM, Benz EJ Jr. Progress in Cancer Research, Prevention, and Care. N Engl J Med. 2020 Sep 3;383(10):897-900. doi: 10.1056/NEJMp2007839. No abstract available. PMID 32877579
- BACKGROUNDAdler A, Geiger S, Keil A, Bias H, Schatz P, deVos T, Dhein J, Zimmermann M, Tauber R, Wiedenmann B. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014 Oct 17;14:183. doi: 10.1186/1471-230X-14-183. PMID 25326034
- BACKGROUNDLuo H, Zhao Q, Wei W, Zheng L, Yi S, Li G, Wang W, Sheng H, Pu H, Mo H, Zuo Z, Liu Z, Li C, Xie C, Zeng Z, Li W, Hao X, Liu Y, Cao S, Liu W, Gibson S, Zhang K, Xu G, Xu RH. Circulating tumor DNA methylation profiles enable early diagnosis, prognosis prediction, and screening for colorectal cancer. Sci Transl Med. 2020 Jan 1;12(524):eaax7533. doi: 10.1126/scitranslmed.aax7533. PMID 31894106
- BACKGROUNDGrotowski M. [Antigens (CEA and CA 19-9) in diagnosis and prognosis colorectal cancer]. Pol Merkur Lekarski. 2002 Jan;12(67):77-80. Polish. PMID 11957811
- BACKGROUNDKanwal R, Gupta K, Gupta S. Cancer epigenetics: an introduction. Methods Mol Biol. 2015;1238:3-25. doi: 10.1007/978-1-4939-1804-1_1. PMID 25421652
- BACKGROUNDShen SY, Singhania R, Fehringer G, Chakravarthy A, Roehrl MHA, Chadwick D, Zuzarte PC, Borgida A, Wang TT, Li T, Kis O, Zhao Z, Spreafico A, Medina TDS, Wang Y, Roulois D, Ettayebi I, Chen Z, Chow S, Murphy T, Arruda A, O'Kane GM, Liu J, Mansour M, McPherson JD, O'Brien C, Leighl N, Bedard PL, Fleshner N, Liu G, Minden MD, Gallinger S, Goldenberg A, Pugh TJ, Hoffman MM, Bratman SV, Hung RJ, De Carvalho DD. Sensitive tumour detection and classification using plasma cell-free DNA methylomes. Nature. 2018 Nov;563(7732):579-583. doi: 10.1038/s41586-018-0703-0. Epub 2018 Nov 14.