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
NCT ID: NCT06903325
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-10-01
2027-10-31
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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POM1 positive
Patients whose 1-month-postoperative plasma ctDNA methylation status is positive
As an observational study, we did not intervene
Interventions
POM1 negative
Patients whose 1-month-postoperative plasma ctDNA methylation status is negative
As an observational study, we did not intervene
Interventions
Interventions
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As an observational study, we did not intervene
Interventions
Eligibility Criteria
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Inclusion Criteria
7\. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Fudan University
OTHER
Responsible Party
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Guoxiang Cai
Professor
Principal Investigators
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Guoxiang Cai
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Weijing Zhang
Role: primary
Other Identifiers
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CRIP-ctDNA
Identifier Type: -
Identifier Source: org_study_id