Study of Plasma ctDNA Methylation to Predict Recurrence of Colorectal Cancer After Complete Surgery for Peritoneal Metastases

What this Trial Is About

Researchers are studying colorectal cancer patients with peritoneal metastasis who have undergone complete or near-complete tumor removal surgery R0R1 resection. The study aims to explore how the methylation status of circulating tumor DNA ctDNA in plasma after surgery can predict the length of time patients remain free from cancer recurrence. This observational study collects clinical data and uses advanced testing to better understand the relationship between ctDNA methylation and patient outcomes. Participants have their plasma tested for ctDNA methylation before surgery, one month after surgery, every three months up to 24 months, and whenever cancer recurrence is detected on imaging. The tests include ColonAiQ and GutSeer methylation techniques applied to blood plasma and tissue samples collected at specific time points. Patients are grouped based on their one-month postoperative plasma ctDNA methylation status as either positive or negative. During the study, participants follow regular hospital review protocols according to NCCN guidelines, including CT or MRI scans and blood CEA tests every three months. Blood samples for plasma separation and ctDNA testing are collected at scheduled intervals to monitor changes over time. The main outcome measured is the ability of ColonAiQ to predict recurrence-free survival, with secondary measures comparing GutSeer and dynamic ctDNA monitoring. The study follows patients for at least 24 months after surgery, with ongoing monitoring to assess disease progression and recurrence.

A Prospective Multicentre Clinical Study of Dynamic Monitoring of Plasma ctDNA Methylation Markers to Predict Recurrence of Colorectal Cancer After Complete Resection of Peritoneal Metastases