Actively Recruiting
Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort
Led by Niguarda Hospital · Updated on 2026-04-17
250
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying metastatic colorectal cancer (mCRC) patients to understand how well anti-EGFR retreatment works when selected based on ctDNA analysis. This observational, retrospective, international, and multicenter study focuses on patients with MSS mCRC who have been screened for RAS/BRAF/PIK3CA mutations using liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The goal is to assess the effectiveness of anti-EGFR rechallenge treatments in a large real-world patient group. The study collects existing clinical and molecular data from participating centers, including patient age, gender, ethnicity, tumor histology, molecular profiles from tissue and liquid biopsies, and treatment histories. It tracks responses to therapies using RECIST v1.1 criteria and evaluates outcomes such as response rate, disease control rate, duration of response, progression-free survival, time-to-treatment failure, and overall survival. Patients included are those screened for ctDNA within the MEN1611-02 clinical trial. Participants' data on diagnosis dates, performance status, metastasis sites, and treatments received after ctDNA analysis are collected retrospectively. Researchers review clinical outcomes and survival data up to two years to evaluate the efficacy of anti-EGFR rechallenge. Since this is a retrospective observational study, there is no new treatment or intervention administered, and participants' usual care is not affected.
CONDITIONS
Brief Title
Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort (the REalCHALLENGE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with MSS RAS and BRAF wild-type metastatic colorectal cancer and screened by ctDNA within the MEN1611-02 clinical trial
- Signed informed consent from alive patients
- Availability of clinical data on outcome to first treatment after ctDNA analysis as per MEN1611-02 trial
- Signed informed consent for molecular screening within the MEN1611-02 clinical trial
- Age 18 years or older
You will not qualify if you...
- No clinical data available on outcome to first treatment after ctDNA analysis as per MEN1611-02 trial
- Patients enrolled and treated within the MEN1611-02 clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to two years
Participants are observed over time to collect clinical data and monitor outcomes related to metastatic colorectal cancer and anti-EGFR retreatment.
Visits as per routine clinical care and data collection schedules
Trial Site Locations
Total: 1 location
1
ASST GOM Niguarda
Milan, Italia, Italy
Actively Recruiting
Research Team
S
Salvatore Siena, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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