Clinical Trial

Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer

Study acronym: CLEAR-01
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.
Trial Details
NCT Number NCT07562659
Lead Sponsor Fudan University
Conditions ctDNA, Colorectal Cancer (CRC), Adjuvant Chemotherapy
Enrollment 80 participants
Start Date 2024-11-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-01