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

Colorectal Cancer Clinical Trial

Official title:

Based on the Application of Peripheral Blood Polygene Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444491
• Other study ID #: Protector-C
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Singlera Genomics Inc.
• Contact: Zheng Liu, Doctor
• Phone: 13621187208
• Email: zheng.liu[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 liver metastasis at the time of diagnosis) and feasible radical bowel resection or complete 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 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 requiring emergency treatment;

4. Colorectal cancer was diagnosed with extrahepatic metastasis;

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

6. Radical bowel resection was performed after endoscopic surgery;

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

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 the researcher.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

Locations

Country	Name	City	State
China	Cancer hospital Chinese academy of medical sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Singlera Genomics Inc.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish a clinical cohort for colorectal cancer	It is expected that 1200 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
Primary	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