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ALFAOMEGA-RETRÒ will be exploited to retrospectively collect clinical and imaging data and archival samples to be used for validation and correlative studies on markers discovered by cutting-edge translational projects within the AIRC5x1000 program "Insights into the evolving heterogeneity of colorectal cancer (CRC): from mechanism to therapies" (an ongoing multi-institutional research program).
ALFAOMEGA-RETRÒ, the retrospective "mirror" protocol of ALFAOMEGA (protocol n. IFOM-CPO003/2018/PO002), has been designed to build a retrospective collection of clinically annotated data and biological samples retrieved from colorectal cancer patients (CRC).
The repository will feed experimental precision research aimed at i) defining a new taxonomy of CRC based on evolutionary patterns (retrospectively assessed on patient's samples), ii) developing and evaluating innovative biomarker-specific therapeutic strategies derived from or together with ALFAOMEGA.
The following data and biological samples will be collected:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of CRC patients | Stage-mixed cohort of at least 500 CRC patients that cannot be reached for informed consent (death or lost-to-follow-up) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Retrospective Observation of standard clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrospectively recruited CRC cases | Number of retrospectively recruited CRC cases with complete matched clinical data, radio-imaging data and FFPE or frozen biological samples. | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of new prognostic and predictive markers | Number of identified/validated new independent prognostic and predictive biomarkers | 6 months |
| Biomarkers correlation with PFS | Correlation of new prognostic and predictive biomarkers with progression-free survival (PFS). |
Inclusion Criteria:
Exclusion Criteria:
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at least 500 colorectal cancer patients at any stage who cannot be reached for an informed consent
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Lazzari, PhD | Contact | +3902574303799 | clinical.trials@ifom.eu | |
| Smeralda Rapisarda | Contact | +3902574303236 | clinical.trials@ifom.eu |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Marsoni, MD | IFOM ETS - The AIRC Institute of Molecular Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Policlinico San Martino | Recruiting | Genova | GE | 16132 | Italy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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FFPE tissue Frozen biological samples (whole blood, plasma, PBMC, stools, buccal swabs, urines)
| 6 months |
| Biomarkers correlation with OS | Correlation of new prognostic and predictive biomarkers with overall survival (OS). | 6 months |
| Fondazione IRCCS, Istituto Nazionale dei Tumori | Recruiting | Milan | MI | 20133 | Italy |
|
| Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | MI | 20162 | Italy |
|
| IRCCS Istituto Clinico Humanitas | Recruiting | Milan | MI | Italy |
|
| Istituto Oncologico Veneto (IOV) | Recruiting | Padua | PD | 35128 | Italy |
|
| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | Pisa | 56126 | Italy |
|
| Istituto di Candiolo - IRCCS | Recruiting | Candiolo | TO | 10060 | Italy |
|
| Azienda Ospedaliero Universitaria San Luigi Gonzaga | Recruiting | Orbassano | TO | 10043 | Italy |
|
| Azienda Ospedaliera Ordine Mauriziano | Active, not recruiting | Torino | TO | 10128 | Italy |
| Institut Català D'Oncologia (ICO) | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
|
| Hospital del Mar - Parc de Salut Mar | Recruiting | Barcelona | 08003 | Spain |
|
| Vall d'Hebron Institute of Oncology (VHIO) | Recruiting | Barcelona | 08035 | Spain |
|
| INCLIVA - Instituto de Investigatión Sanitaria | Recruiting | Valencia | 46010 | Spain |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |