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

NCT05444491 | Active Not Recruiting

• 1 other identifier: Protector-C
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Colorectal Cancer

Keywords

ctDNA methylation; Recurrence monitoring

Outcome Measures

Primary Outcomes (2)

• To establish a clinical cohort for colorectal cancer

  It is expected that 800 patients with primary colorectal cancer diagnosed clinically will be enrolled for screening. Plasma samples 1-2 days before radical bowel resection will be collected for ColonAiQ polygene methylation test. Follow-up will be conducted 2 years after surgical resection, including CT/MRI imaging evaluation and blood CEA, etc. And dynamic monitoring of plasma ctDNA methylation level. Blood samples were collected for 9 times.

  assessed up to 36 months

• To investigate the prediction and monitoring effect of plasma ctDNA methylation on postoperative recurrence of primary colorectal cancer patients after radical surgery

  To investigate the role of peripheral plasma ctDNA methylation level at different time points in the monitoring of disease recurrence after radical bowel resection for primary colorectal cancer, the multi-gene methylation detection of peripheral plasma ctDNA was conducted before, after and during the postoperative follow-up period.

  assessed up to 36 months

Study Arms (2)

MRD positive group

ColonAiQ polygene methylation test was performed on peripheral blood plasma samples from the enrolled patients 4 weeks after surgery. If gene methylation levels in the samples exceeded the threshold, the patients were enrolled in the MRD positive group. The 2-year total tumor recurrence rate of patients in the MRD positive group was calculated, and the positive prediction rate of postoperative plasma ctDNA methylation-MRD detection results for 2-year tumor recurrence rate after colorectal cancer radical resection was calculated.

MRD negative group

ColonAiQ polygene methylation test was performed on peripheral blood plasma samples from the enrolled patients 4 weeks after surgery. If the gene methylation level detected in the samples did not exceed the threshold, the patients were enrolled in the MRD negative group. The 2-year total tumor recurrence rate of patients in the negative MRD group was calculated, and the negative prediction rate of postoperative plasma ctDNA methylation-MRD test results for 2-year tumor recurrence rate after radical resection of colorectal cancer was calculated.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

800 patients with initial clinical diagnosis of primary colorectal cancer

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Colorectal cancer was diagnosed with extrahepatic metastasis;
• Neoadjuvant therapy (such as radiotherapy and chemotherapy) before radical bowel resection;
• Radical bowel resection was performed after endoscopic surgery;
• Concomitant symptoms and/or family history collection suggest hereditary colorectal cancer;
• serious mental illness or drug abuse;
• patients with serious heart, lung and vascular diseases who cannot tolerate surgery;
• pregnant or lactating women;
• Participate in other interventional clinical investigators within 3 months
• Poor compliance, unable to complete the study according to the judgment of the researcher.

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (7)

Cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, 100029, China

Location

West China Hospital

Chengdu, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

The Second Affiliated Hospital of Harbin Medical University

Haerbin, China

Location

The First Affiliated Hospital of Naval Medical University/ Changhai Hospital

Shanghai, China

Location

Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

Location

Shanxi Cancer hospital (Shanxi Cancer institute)

Taiyuan, China

Location

Related Publications (2)

• Young PE, Womeldorph CM, Johnson EK, Maykel JA, Brucher B, Stojadinovic A, Avital I, Nissan A, Steele SR. Early detection of colorectal cancer recurrence in patients undergoing surgery with curative intent: current status and challenges. J Cancer. 2014 Mar 15;5(4):262-71. doi: 10.7150/jca.7988. eCollection 2014.

  PMID: 24790654 BACKGROUND

• Pantel K, Alix-Panabieres C. Tumour microenvironment: informing on minimal residual disease in solid tumours. Nat Rev Clin Oncol. 2017 Jun;14(6):325-326. doi: 10.1038/nrclinonc.2017.53. Epub 2017 Apr 11. No abstract available.

  PMID: 28397823 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rui Liu, Doctor

  Singlera Genomics Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: July 6, 2022
• Study Start: June 20, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)