RecruitingNot Applicable

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)

Italy250 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC and screened by ctDNA within the MEN1611-02 clinical trial;
✓. Informed consent signature from alive patient;
✓. 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;
✓. Signed informed consent for molecular screening within the MEN1611-02 clinical trial.
✓. Age ≥ 18.

Exclusion criteria

✕. 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.
✕. Patients enrolled and treated within the MEN1611-02 clinical trial.

What they're measuring

Efficacy anti-EGFR rechallenge

Timeframe: Up to two years

Trial details

NCT IDNCT07536113

SponsorNiguarda Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-01

Contact for this trial

Salvatore Siena, MD

+39026444 salvatore.siena@ospedaleniguarda.it

View on ClinicalTrials.gov More Metastatic Colorectal Cancer (CRC) trials