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Recruiting NCT05536089

ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

Trial Parameters

Condition Cancer Colorectal
Sponsor Singlera Genomics Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-05
Completion 2028-09
Interventions
a multi-locus blood-based assay

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.

Eligibility Criteria

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

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