Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients

FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients (NCT07558083) is a Phase 3 interventional studying Advanced Colorectal Cancer, sponsored by University Hospital, Antwerp. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Advanced Colorectal Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Colorectal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Man or woman ≥ 18 years of age at the time the willing to sign a consent form is obtained - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 - diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: - History of prior or concurrent cancer that has spread to the brain - 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 - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * History of prior or concurrent central nervous system metastases * 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 * 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. * Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.

Treatments Being Tested

OTHER

Evaluation therapy through Liquid Biopsy

The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

AZ Sint Maarten

Mechelen, Antwerpen, Belgium

AZ Klina

Brasschaat, Antwerp, Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium

Sint-Augustinus (ZAS)

Wilrijk, Antwerp, Belgium

Grand Hopital de Charleroi

Charleroi, Henegouwen, Belgium

AZ Maria Middelares, Ghent

Ghent, Oost-Vlaanderen, Belgium

Vitaz

Sint-Niklaas, Oost-Vlaanderen, Belgium

AZ Sint Lucas, Brugge

Bruges, West-Vlaanderen, Belgium

AZ Groeninge, Kortrijk

Kortrijk, West-Vlaanderen, Belgium

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07558083), the sponsor (University Hospital, Antwerp), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07558083 clinical trial studying?

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 q… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07558083?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07558083?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07558083. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07558083. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.