RecruitingNCT06903325

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


Sponsor

Fudan University

Enrollment

50 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood test that detects cancer DNA (ctDNA methylation markers) to monitor for colorectal cancer recurrence after surgery to remove cancer that had spread to the abdominal lining (peritoneal metastases). The goal is to catch relapse earlier than standard imaging. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of colorectal adenocarcinoma (or related type) - You have had surgery (cytoreductive surgery, CRS) that successfully removed all visible cancer from the abdominal cavity (R0/R1 resection) - Your peritoneal cancer score was 20 or below before surgery - You have no cancer spread outside the abdomen (except possibly the ovaries) - You are in good health (ECOG ≤1) with at least 2 years life expectancy **You may NOT be eligible if...** - You have another active cancer within the past 5 years (with certain exceptions) - You have severe psychiatric illness or substance abuse - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAs an observational study, we did not intervene

Interventions


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06903325


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