An observational study in Metastatic Colorectal Cancer (CRC), sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Niguarda Hospital · Observational
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.
Patient's data to be collected include: age, gender, ethnicity; Eastern Cooperative Oncology Group scale performance status (ECOGPS); date of first diagnosis and date of advanced CRC diagnosis; primary tumor histology; timing of collection of FFPE and liquid biopsy samples; molecular profile data both from archival solid tissue and liquid biopsy; number and sites of metastasis at the time of liquid biopsy draw; medical treatment regimens, lines and locoregional approaches pursued, focusing on the first treatment received by patients following ctDNA analysis; date of death or last follow up. Response evaluation to therapies have to be assessed according to Response Evaluation Criteria in solid tumors (RECIST v1.1) criteria. Information will be provided about resposne to standard treatments (RR and DCR), duration of response (DOR), progression-free survival (PFS), time-to-treatment failure (TTF), OS.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 250 is close to the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with mCRC and screened by ctDNA within the MEN1611-02 clinical trial.
Efficacy anti-EGFR rechallenge
The study aims primarily at assessing the efficacy of anti-EGFR rechallenge in the largest real-world cohort of MSS mCRC patients according to RAS/BRAF/PIK3CA ctDNA status taking advantage from the liquid biopsy screening performed as per MEN1611-02 C-PRECISE-01 trial.
Time frame: Up to two years
Plan to share: Undecided — not yet decided
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for May 2026, 26 months after the start.
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Niguarda Hospital