Monitoring colorectal cancer recurrence using blood tests

Based on the Application of Peripheral Blood Polygene Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer

This study is testing if blood tests can help people with colorectal cancer find out earlier if their cancer comes back after surgery.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Singlera Genomics Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05444491 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with stage I-IV colorectal cancer who are undergoing radical surgical resection. It involves collecting plasma samples to detect polygene methylation levels before and after surgery, as well as during follow-up visits over a two-year period. The goal is to evaluate how these methylation markers can predict postoperative recurrence and assess the efficacy of adjuvant chemotherapy. By monitoring these levels dynamically, the study aims to identify tumor recurrence and metastasis earlier than traditional imaging methods.

Who should consider this trial

Good fit: Ideal candidates include newly diagnosed patients with stage I-III colorectal cancer or stage IV patients with liver metastasis who are eligible for radical surgery.

Not a fit: Patients with extrahepatic metastasis or those who have received neoadjuvant therapy prior to surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of colorectal cancer recurrence, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using ctDNA methylation for monitoring cancer recurrence, suggesting this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Cancer hospital Chinese academy of medical sciences — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Rui Liu, Doctor — Singlera Genomics Inc.
• Study coordinator: Zheng Liu, Doctor

Conditions: Colorectal Cancer, ctDNA methylation, Recurrence monitoring