Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal… (NCT05444491) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer
China800 participantsStarted 2022-06-20
Plain-language summary
This study dynamically monitored the prognosis of stage I-IV colorectal cancer patients who could receive radical surgical resection by detecting the levels of polygene methylation in plasma samples from patients with colorectal cancer. In patients with colorectal cancer feasible radical surgery, plasma ctDNA methylation detection was performed before and after surgical treatment and during regular follow-up to explore the predictive effect of plasma ctDNA methylation status at different time points on postoperative recurrence. To explore whether postoperative dynamic monitoring of plasma ctDNA methylation can be used for adjuvant chemotherapy efficacy evaluation and whether it can indicate tumor recurrence and metastasis earlier than imaging examination.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);
✓. Patients diagnosed as stage I-III and feasible for radical bowel surgery;
✓. Patients diagnosed by stage IV (only colorectal cancer patients with liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete resection of liver metastasis;
✓. No gender limitation, age ≥18;
✓. ECOG score ≤1;
✓. Life expectancy ≥5 years;
✓. Those who fully understand the study and voluntarily sign the informed consent.
Exclusion criteria
✕. Blood transfusion was performed during surgery or 2 weeks before surgery;
✕. complicated with primary malignant tumors of other organs;
✕. With colonic obstruction, intestinal perforation and other symptoms requiring emergency treatment;
What they're measuring
1
To establish a clinical cohort for colorectal cancer
Timeframe: assessed up to 36 months
2
To investigate the prediction and monitoring effect of plasma ctDNA methylation on postoperative recurrence of primary colorectal cancer patients after radical surgery