ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer Colorectal

Intervention / Treatment
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* Diagnostic Test: a multi-locus blood-based assay


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ctDNA positive<br>Postoperative ctDNA positive | Diagnostic Test: a multi-locus blood-based assay<br>* Colorectal tumor-specific plasma ctDNA methylation markers detection<br>|
| ctDNA negative<br>Postoperative ctDNA negative | Diagnostic Test: a multi-locus blood-based assay<br>* Colorectal tumor-specific plasma ctDNA methylation markers detection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early detection