Clinical trial · Observational
Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer
Based on the Application of Peripheral Blood Polygene Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer
- 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 dynamically monitored the prognosis of stage I-IV colorectal cancer patients who could receive radical surgical resection by detecting the levels of polygene methylation in plasma samples from patients with colorectal cancer. In patients with colorectal cancer feasible radical surgery, plasma ctDNA methylation detection was performed before and after surgical treatment and during regular follow-up to explore the predictive effect of plasma ctDNA methylation status at different time points on postoperative recurrence. To explore whether postoperative dynamic monitoring of plasma ctDNA methylation can be used for adjuvant chemotherapy efficacy evaluation and whether it can indicate tumor recurrence and metastasis earlier than imaging examination.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- MRD positive group
- description
- ColonAiQ polygene methylation test was performed on peripheral blood plasma samples from the enrolled patients 4 weeks after surgery. If gene methylation levels in the samples exceeded the threshold, the patients were enrolled in the MRD positive group. The 2-year total tumor recurrence rate of patients in the MRD positive group was calculated, and the positive prediction rate of postoperative plasma ctDNA methylation-MRD detection results for 2-year tumor recurrence rate after colorectal cancer radical resection was calculated.
- label
- MRD negative group
- description
- ColonAiQ polygene methylation test was performed on peripheral blood plasma samples from the enrolled patients 4 weeks after surgery. If the gene methylation level detected in the samples did not exceed the threshold, the patients were enrolled in the MRD negative group. The 2-year total tumor recurrence rate of patients in the negative MRD group was calculated, and the negative prediction rate of postoperative plasma ctDNA methylation-MRD test results for 2-year tumor recurrence rate after radical resection of colorectal cancer was calculated.
Primary outcomes (2)
- measure
- To establish a clinical cohort for colorectal cancer
- timeFrame
- assessed up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type); 2. Patients diagnosed as stage I-III and feasible for radical bowel surgery; 3. Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete resection of liver metastasis; 4. No gender limitation, age ≥18; 5. ECOG score ≤1; 6. Life expectancy ≥5 years; 7. Those who fully understand the study and voluntarily sign the informed consent. Exclusion Criteria: 1. Blood transfusion was performed during surgery or 2 weeks before surgery; 2. complicated with primary malignant tumors of other organs; 3. With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment; 4. Colorectal cancer was diagnosed with extrahepatic metastasis; 5. Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection; 6. Radical bowel resection was performed after endoscopic surgery; 7. Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer; 8. serious mental illness or drug abuse; 9. patients with serious heart, lung and vascular diseases who cannot tolerate surgery; 10. pregnant or lactating women; 11. Participate in other interventional clinical investigators within 3 months 12. Poor compliance, unable to complete the study according to the judgment of the researcher.
References
Publications (2)
- BACKGROUNDYoung PE, Womeldorph CM, Johnson EK, Maykel JA, Brucher B, Stojadinovic A, Avital I, Nissan A, Steele SR. Early detection of colorectal cancer recurrence in patients undergoing surgery with curative intent: current status and challenges. J Cancer. 2014 Mar 15;5(4):262-71. doi: 10.7150/jca.7988. eCollection 2014. PMID 24790654
- BACKGROUNDPantel K, Alix-Panabieres C. Tumour microenvironment: informing on minimal residual disease in solid tumours. Nat Rev Clin Oncol. 2017 Jun;14(6):325-326. doi: 10.1038/nrclinonc.2017.53. Epub 2017 Apr 11. No abstract available. PMID 28397823