Actively Recruiting
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
Led by Fudan University · Updated on 2025-03-30
50
Participants Needed
1
Research Sites
213 weeks
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
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.
CONDITIONS
Official 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 score of 1 or less
- Life expectancy of 2 years or more
- Histopathological confirmation of colorectal adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma
- Preoperative PCI score of 20 or less
- Underwent peritoneal tumor cytoreductive surgery achieving R0 or R1 resection
- Able to understand the study and provide informed consent
- Primary colorectal cancer has undergone R0 resection
- No extraperitoneal metastasis except ovary
You will not qualify if you...
- Presence of other primary malignant tumors currently or within past 5 years (except 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 making surgery intolerable
- Pregnant or lactating women
AI-Screening
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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
CONTACT
L
Lingyu Han, MD, PhD
CONTACT
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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