RecruitingNCT07536113

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)

Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort


Sponsor

Niguarda Hospital

Enrollment

250 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • 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.

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Locations(1)

ASST GOM Niguarda

Milan, Italia, Italy

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NCT07536113


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