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

Recruiting

• Conditions: Colorectal Cancer; Peritoneal Metastases

• Registration Number: NCT06903325
• Lead Sponsor: Fudan University

Brief Summary

The goal of this clinical trial is to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis after R0/R1 resection. The main questions it aims to answer are:

Preoperative and postoperative plasma ctDNA methylation detection (ColonAiQ) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection. Clinical information of patients was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.

Participants will:

The patients were followed up according to the normal review procedure of the hospital and the NCCN guidelines until at least 24 months after surgery. The review content included CT/MRI imaging evaluation and blood CEA (every 3 months). Whole-blood samples were obtained for timely plasma separation and ctDNA extraction at 1 month after surgery (before the start of postoperative chemotherapy) and every 3 months through 24 months after surgery. One blood sample was obtained when tumor recurrence was first detected on imaging.

Detection of methylation in tissue and plasma samples

1. GutSeer methylation NGS was performed on peritoneal metastatic cancer tissues and paired normal peritoneal tissues.

2. ctDNA GutSeer methylation NGS was performed on plasma samples before surgery, 1 month after surgery, 24 months after surgery, and when tumor recurrence was first detected by imaging examination.

3. ctDNA methylation PCR (ColonAiQ) was performed on plasma samples before surgery, 1 month after surgery, every 3 months to 24 months after surgery, and when tumor recurrence was first detected by imaging examination.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

-1. No gender limit, age greater than 18 years old; 2, ECOG score ≤1; 3. Life expectancy ≥2 years; 4. Colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative PCI score ≤20, peritoneal tumor cytoreductive surgery (CRS), surgery to achieve R0/1 resection; 6. Be able to understand the situation of this study and sign the informed consent.

7. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary).

Exclusion Criteria

• 1. Combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. Severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. Pregnant or lactating women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
predictive value of ColonAiQ postoperative recurrence free survival (RFS)	2023.10-2027.10	explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.

Secondary Outcome Measures

Name	Time	Method
predictive value of GutSeer for RFS	2023.10-2027.10	Preoperative and postoperative plasma ctDNA polygene methylation test (GutSeer) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection, and the clinical information of patients' recurrence-free survival (RFS) was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative RFS of colorectal cancer peritoneal metastasis.
predictive value of ctDNA for dynamic monitoring	2023.10-2027.10	To explore the predictive value of plasma ctDNA methylation status before surgery, after postoperative adjuvant chemotherapy, and regularly monitored after surgery for recurrence and metastasis of colorectal cancer patients with peritoneal metastasis
difference of predictive value of ColonAiQ and GutSeer	2023.10-2027.10	Compare the prognostic value of GutSeer and ColonAiQ and CEA at 1 month after surgery;
the advance time of dynamic detection of plasma ctDNA methylation compared with imaging monitoring	2023.10-2027.10	To explore the advance time of dynamic detection of plasma ctDNA methylation compared with imaging monitoring in monitoring recurrence after complete resection of peritoneal metastasis from colorectal cancer

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China