ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

Recruiting

• Conditions: Cancer Colorectal
• Interventions: Diagnostic Test: a multi-locus blood-based assay

• Registration Number: NCT05536089
• Lead Sponsor: Singlera Genomics Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2022-09-05
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2028-09
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ctDNA negative	a multi-locus blood-based assay	Postoperative ctDNA negative
ctDNA positive	a multi-locus blood-based assay	Postoperative ctDNA positive

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3y DFS	3 years	The 3-year disease free survival rate of the patients from both cohorts.

Trial Locations

Locations (1)

Second Affiliated Hospital; 🇨🇳 Hangzhou, Zhejiang, China