NCT05444491Active, not recruiting
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 · Last updated 31 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 25 Jun 2022
- Start date
- 20 Jun 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Singlera Genomics Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT05444491
What you commit to
- Study type: Observational
- Planned participants: 800
- From 20 Jun 2022 to the primary completion date, 30 Jun 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood transfusion was performed during surgery or 2 weeks before surgery;
- Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection;
- Radical bowel resection was performed after endoscopic surgery;
- Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer;
Other illness
- complicated with primary malignant tumors of other organs;
- With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment;
- Colorectal cancer was diagnosed with extrahepatic metastasis;
- serious mental illness or drug abuse;
- patients with serious heart, lung and vascular diseases who cannot tolerate surgery;
Other
- pregnant or lactating women;
- Participate in other interventional clinical investigators within 3 months
- Poor compliance, unable to complete the study according to the judgment of the researcher.
Who the study is looking for
- Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);
- Patients diagnosed as stage I-III and feasible for radical bowel surgery;
- 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;
- No gender limitation, age ≥18;
- ECOG score ≤1;
- Life expectancy ≥5 years;
- Those who fully understand the study and voluntarily sign the informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Haerbin | China | Unknown status |
| The First Affiliated Hospital of Naval Medical University/ Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Chinese Academy of Medical Sciences, Shenzhen Center Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shanxi Cancer hospital (Shanxi Cancer institute) Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.