FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
NCT07558083 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-04-30
Summary
The FOLICOLOR trial aims to evaluate whether a liquid biopsy-guided follow-up strategy can improve outcomes in patients with unresectable, metastatic colorectal cancer (mCRC) receiving first-line systemic treatment. The approach uses NPY methylation-based circulating tumor DNA (ctDNA) analysis from blood samples to monitor treatment response and guide clinical decision-making. Eligible patients are adults diagnosed with unresectable, metastatic colorectal cancer who are starting first-line treatment. The primary goal is to demonstrate a clinically meaningful benefit, particularly in terms of quality of life (QoL) and reduction of treatment-related toxicity, by allowing earlier and more personalized therapeutic adjustments based on liquid biopsy findings.
Conditions
- Advanced Colorectal Cancer
Interventions
- OTHER
-
Evaluation therapy through Liquid Biopsy
The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results
Sponsors & Collaborators
-
Kom Op Tegen Kanker
collaborator OTHER -
University Hospital, Antwerp
lead OTHER
Principal Investigators
-
Timon Vandamme · University Hospital, Antwerp
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-16
- Primary Completion
- 2029-12-31
- Completion
- 2031-08-31
Countries
- Belgium
Study Locations
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