ctDNA-driven Anti-EGFR Retreatment Metastatic Colorectal Cancer Study
Summary
NIH's ClinicalTrials.gov registered NCT07536113, an observational, retrospective, international multicenter study evaluating anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients. The study, funded by Fondazione Oncologia Niguarda ETS, will screen patients for RAS/BRAF/PIK3CA ctDNA status via liquid biopsy within the MEN1611-02 C-PRECISE-01 trial and collect molecular, clinical, and outcome data already available at participating centers.
What changed
This is a ClinicalTrials.gov registry entry for a new observational study (NCT07536113) examining anti-EGFR rechallenge in metastatic colorectal cancer patients selected via circulating tumor DNA (ctDNA) liquid biopsy. The retrospective study will analyze molecular, clinical, and outcome data from patients already treated at participating international centers.
For compliance and regulatory professionals, this registry entry documents a clinical research initiative rather than imposing compliance obligations. Clinical investigators and trial sponsors should note the study's liquid biopsy screening criteria (RAS/BRAF/PIK3CA) and its integration with the MEN1611-02 C-PRECISE-01 parent trial. No regulatory actions, reporting requirements, or compliance deadlines are established by this registry entry.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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)
Observational NCT07536113 Kind: OBSERVATIONAL Apr 17, 2026
Abstract
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.
Conditions: Metastatic Colorectal Cancer (CRC)
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