A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)

Study Overview
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Brief Summary
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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).

Detailed Description
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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: Clinical Data (Demographics, Medical History, Cancer Diagnosis & History, Treatment Assessment,). Imaging Data (CT-Scans, MRI, PET...). Formalin-Fixed Paraffin-Embedded (FFPE) tissue (either from surgical resections or diagnostic biopsies). Frozen biological samples (blood, plasma, PBMC, stools, buccal swabs, urines, etc.).

Official Title
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A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically-confirmed diagnosis of colorectal cancer (any stage). Age >18 years at the time of diagnosis. Availability of clinically-annotated radio-imaging data and/or diagnostic Formalin-Fixed Paraffin Embedded (FFPE) blocks (surgical resections and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides. Verification that the patient could not be reached for informed consent in accordance with applicable national regulations. Exclusion Criteria: if inclusion criteria are not met

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of CRC patients<br>Stage-mixed cohort of at least 500 CRC patients that cannot be reached for informed consent (death or lost-to-follow-up) | Other: Observation<br>* Retrospective Observation of standard clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, CRC, Gastrointestinal disease