ctDNA-guided anti-EGFR retreatment in metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, observational, international multicenter effort to collect clinical, molecular and outcome data from MSS, RAS/BRAF wild‑type metastatic colorectal cancer patients who were screened by ctDNA within the MEN1611‑02 protocol. The study compiles archival tissue and liquid biopsy molecular profiles (RAS/BRAF/PIK3CA), timing of sample collection, patient demographics, ECOG performance status, metastasis sites, prior treatments and the first treatment given after the ctDNA draw. Responses will be recorded using RECIST v1.1 and outcomes will include response rate, disease control rate, duration of response, progression‑free survival, time‑to‑treatment failure and overall survival. Analyses will compare real‑world outcomes for patients selected or not selected for anti‑EGFR retreatment based on ctDNA findings.

Why it matters

Who can join: the full rules

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.

Where it's running

• ASST GOM Niguarda
  Milan, Italia, Italy Recruiting

Study contacts

• Principal investigator: Salvatore Siena, MD — ASST Niguarda Hospital
• Study coordinator: Salvatore Siena, MD
• Email: salvatore.siena@ospedaleniguarda.it
• Phone: +39026444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.