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Clinical Trials in Italy / NCT07536113
Recruiting Observational

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)

NCT07536113 · tracked via the Priya Life Science Italy tracker
Sponsor
Niguarda Hospital
Phase
Observational
Started
2024-03-01
Last updated
2026-04-17

Condition(s) studied

Metastatic Colorectal Cancer (CRC)

Study summary

This is an observational, retrospective, international and multicenter study funded by Fondazione Oncologia Niguarda ETS to assess the efficacy of anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients screened for RAS/BRAF/PIK3CA ctDNA status on liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The study will collect molecular, clinical and outcome data of patients already available at participating centers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria 1. Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC and screened by ctDNA within the MEN1611-02 clinical trial; 2. Informed consent signature from alive patient; 3. Availability of clinical data detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial; 4. Signed informed consent for molecular screening within the MEN1611-02 clinical trial. 5. Age ≥ 18. Exclusion criteria 1. No data available detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial. 2. Patients enrolled and treated within the MEN1611-02 clinical trial.

Primary outcome measure(s)

  • Efficacy anti-EGFR rechallenge — Up to two years
    The study aims primarily at assessing the efficacy of anti-EGFR rechallenge in the largest real-world cohort of MSS mCRC patients according to RAS/BRAF/PIK3CA ctDNA status taking advantage from the liquid biopsy screening performed as per MEN1611-02 C-PRECISE-01 trial.

Trial sites (1)

FacilityCityRegionStatus
ASST GOM Niguarda Milan Italia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07536113 on ClinicalTrials.gov ↗ ← All trials in Italy