Blood tests to track treatment response in metastatic colorectal cancer
Tests blood-based tumor DNA monitoring in adults starting first treatment for metastatic colorectal cancer.
Plain-language title generated from the registry record
Registry title: FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
Key facts
- Where
- Brasschaat, Bruges, Charleroi, Edegem, Ghent, Kortrijk, Mechelen, Sint-Niklaas, and Wilrijk, BelgiumSee the 9 sites
- Phase
- Phase 3
Where in Belgium
- AZ KLINABrasschaat, BelgiumTaking people
- AZ Sint Lucas, BruggeBruges, BelgiumTaking people
- Grand Hopital de CharleroiCharleroi, BelgiumTaking people
- University Hospital AntwerpEdegem, BelgiumTaking people
- Az Maria Middelares GhentGhent, BelgiumTaking people
- AZ Groeninge, KortrijkKortrijk, BelgiumTaking people
- AZ Sint MaartenMechelen, BelgiumTaking people
- VitazSint-Niklaas, BelgiumTaking people
- Sint-Augustinus (ZAS)Wilrijk, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Antwerp
- Trial code
- NCT07558083
- Record updated
- 30 April 2026
- Original description
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.Read full original descriptionShow less
FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients
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.
Inclusion: Man or woman ≥ 18 years of age at the time the informed consent is obtained; ECOG performance status of 0-2; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease; There should be at least 1 uni-dimensionally measurable (min. 10mm) using conventional crosssectional imaging techniques (CT or MRI scan). Lesion must not be chosen from a previously irradiated field, unlessnthere has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization; Adequate hematology, renal, hepatic and coagulation function (at treating physician's discretion); Adequate blood results for treatment (at treating physician's discretion); Starting a first line treatment.
Exclusion: History of prior or concurrent central nervous system metastases; Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities; Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib); Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to randomization with the following exceptions: Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer; History of other malignancy, except:; Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease; Adequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer.