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

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ClinicalTrials.gov Identifier: NCT05444491
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : July 6, 2022
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Singlera Genomics Inc.

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.

Condition or disease
Colorectal Cancer

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Based on the Application of Peripheral Blood Polygene Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer
Actual Study Start Date : June 20, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Group/Cohort
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.



Primary Outcome Measures :
  1. To establish a clinical cohort for colorectal cancer [ Time Frame: assessed up to 36 months ]
    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.

  2. To investigate the prediction and monitoring effect of plasma ctDNA methylation on postoperative recurrence of primary colorectal cancer patients after radical surgery [ Time Frame: assessed up to 36 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1200 patients with initial clinical diagnosis of primary colorectal cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05444491


Contacts
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Contact: Zheng Liu, Doctor 13621187208 zheng.liu@cicams.ac.cn

Locations
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China, Beijing
Cancer hospital Chinese academy of medical sciences Recruiting
Beijing, Beijing, China, 100029
Contact: Zheng Liu, Doctor    13621187208    zheng.liu@cicams.ac.cn   
Sponsors and Collaborators
Singlera Genomics Inc.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Rui Liu, Doctor Singlera Genomics Inc.
Publications:
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Responsible Party: Singlera Genomics Inc.
ClinicalTrials.gov Identifier: NCT05444491    
Other Study ID Numbers: KYS-2022004
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singlera Genomics Inc.:
ctDNA methylation
Recurrence monitoring
Additional relevant MeSH terms:
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Colorectal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes