Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer

Last updated: May 21, 2024
Sponsor: Singlera Genomics Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05444491
Protector-C
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Newly diagnosed patients with primary colorectal cancer confirmed by histopathology (no restriction on histological type);

  2. Patients diagnosed as stage I-III and feasible for radical bowel surgery;

  3. Patients diagnosed by stage IV (only colorectal cancer patients with livermetastasis at the time of diagnosis) and feasible radical bowel resection orcomplete resection of liver metastasis;

  4. No gender limitation, age ≥18;

  5. ECOG score ≤1;

  6. Life expectancy ≥5 years;

  7. Those who fully understand the study and voluntarily sign the informed consent.

Exclusion

Exclusion Criteria:

  1. Blood transfusion was performed during surgery or 2 weeks before surgery;

  2. complicated with primary malignant tumors of other organs;

  3. With colonic obstruction, intestinal perforation and other symptoms requiringemergency treatment;

  4. Colorectal cancer was diagnosed with extrahepatic metastasis;

  5. Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowelresection;

  6. Radical bowel resection was performed after endoscopic surgery;

  7. Concomitant symptoms and/or family history collection suggest hereditary colorectalcancer;

  8. serious mental illness or drug abuse;

  9. patients with serious heart, lung and vascular diseases who cannot tolerate surgery;

  10. pregnant or lactating women;

  11. Participate in other interventional clinical investigators within 3 months

  12. Poor compliance, unable to complete the study according to the judgment of theresearcher.

Study Design

Total Participants: 1200
Study Start date:
June 20, 2022
Estimated Completion Date:
June 30, 2025

Study Description

  1. Patients initially diagnosed with primary colorectal cancer were enrolled for screening, and plasma samples 1-2 days before radical bowel resection were collected for polygene methylation detection.

  2. The postoperative follow-up was 2 years, and the reexamination included CT/MRI imaging assessment, blood CEA, and dynamic monitoring of plasma ctDNA methylation level. Blood samples were collected for 9 times.

  3. Results analysis: To explore the application value of ctDNA methylation-MRD detection in the prediction of postoperative tumor recurrence risk after radical resection of colorectal cancer; The correlation between preoperative ctDNA methylation level and prognosis of early colorectal cancer.

Connect with a study center

  • Cancer hospital Chinese academy of medical sciences

    Beijing, Beijing 100029
    China

    Active - Recruiting

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