Actively Recruiting
Dynamic Monitoring of Plasma ctDNA Methylation Markers to Predict Recurrence of Colorectal Cancer After Complete Resection of Peritoneal Metastases
Led by Fudan University · Updated on 2025-03-30
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
S
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying colorectal cancer patients with peritoneal metastasis who have undergone complete or near-complete tumor removal surgery (R0/R1 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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No gender limit, age greater than 18 years old
- ECOG performance status of 1 or less
- Life expectancy of 2 years or more
- Histopathological confirmation of colorectal adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma
- Preoperative Peritoneal Cancer Index (PCI) score of 20 or less
- Underwent peritoneal tumor cytoreductive surgery with R0 or R1 resection
- Primary colorectal cancer has undergone R0 resection with no extraperitoneal metastasis except ovary
- Able to understand the study and provide informed consent
You will not qualify if you...
- Presence of other primary malignant tumors (current or within the past 5 years), excluding skin basal cell carcinoma and cervical carcinoma in situ under radical treatment
- Severe mental illness or history of drug abuse
- Severe heart, lung, or vascular disease that prevents tolerance of surgery
- Pregnant or lactating women
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 years
Participants who have undergone complete resection of peritoneal metastases from colorectal cancer are observed through dynamic monitoring of plasma ctDNA methylation markers to predict cancer recurrence.
Regular blood sample collections over the monitoring period
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
G
Guoxiang Cai, MD, PhD
L
Lingyu Han, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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