ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection

In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.

Study Overview

• Status: Recruiting
• Conditions: Cancer Colorectal
• Intervention / Treatment: Diagnostic test: a multi-locus blood-based assay

Detailed Description

This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Rui Liu, Ph.D; Email: rliu@singleragenomics.com
• Study Contact Backup: Name: HongFeng Cao, Ph.D; Phone Number: 13957117804; Email: hongfengcao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital
      • Contact: HongFeng Cao, Ph.D; Phone Number: 13957117804; Email: hongfengcao@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

Description

Inclusion Criteria:

• Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer.
• Male or female ≥ 18 years of age on the day of signing informed consent.
• Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC).
• Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

• Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
• Induction of neoadjuvant systemic therapy prior to resection of CRC.
• Patient is pregnant or lactating.
• Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
• Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ctDNA positive; Postoperative ctDNA positive	Diagnostic test: a multi-locus blood-based assay; Colorectal tumor-specific plasma ctDNA methylation markers detection
ctDNA negative; Postoperative ctDNA negative	Diagnostic test: a multi-locus blood-based assay; Colorectal tumor-specific plasma ctDNA methylation markers detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5y DFS	The 5-year disease free survival rate of the patients from both cohorts.	5 years
ctDNA methylation markers versus CT/MRI	ctDNA methylation predictors of outcome will be compared to CT/MRI	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3y DFS	The 3-year disease free survival rate of the patients from both cohorts.	3 years

Collaborators and Investigators

• Sponsor: Singlera Genomics Inc.
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Rui Liu, Ph.D, Singlera Genomics Inc.; Study Director: KeFeng Ding, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: early detection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: Recovery-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No