Actively Recruiting

Age: 18Years +
All Genders
NCT07536113

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)

Led by Niguarda Hospital · Updated on 2026-04-17

250

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) metastatic colorectal cancer and screened by ctDNA within the MEN1611-02 clinical trial
  • Signed informed consent from alive patients
  • Availability of clinical data detailing the outcome to the first treatment received following ctDNA analysis as per MEN1611-02 screening
  • Signed informed consent for molecular screening within the MEN1611-02 clinical trial
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • No data available detailing outcome to the first treatment received following ctDNA analysis as per MEN1611-02 screening
  • Patients enrolled and treated within the MEN1611-02 clinical trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

ASST GOM Niguarda

Milan, Italia, Italy

Actively Recruiting

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Research Team

S

Salvatore Siena, MD

CONTACT

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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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) | DecenTrialz