ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

Official title

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

Overview

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.

Interventions

• Diagnostic test a multi-locus blood-based assay
  Colorectal tumor-specific plasma ctDNA methylation markers detection

Primary outcome measures

• 5y DFS [Time frame: 5 years]
• ctDNA methylation markers versus CT/MRI [Time frame: 5 years]

Secondary outcome measures (1)

• 3y DFS [Time frame: 3 years]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Second Affiliated Hospital — Hangzhou

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: PMID 34487783

Identifiers

NCT: NCT05536089 · Recovery-C

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗