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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCRC patients | Patients diagnosed with mCRC and screened by ctDNA within the MEN1611-02 clinical trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to two years |
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Inclusion criteria
Exclusion criteria
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Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Siena, MD | Contact | +39026444 | 3695 | salvatore.siena@ospedaleniguarda.it |
| Name | Affiliation | Role |
|---|---|---|
| Salvatore Siena, MD | ASST Niguarda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST GOM Niguarda | Recruiting | Milan | Italia | Italy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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