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

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Observation

• Registration Number: NCT05101382
• Lead Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology

Brief Summary

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

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.).

Study Timeline

• Study Start: 2020-10-28
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of CRC patients	Observation	Stage-mixed cohort of at least 500 CRC patients that cannot be reached for informed consent (death or lost-to-follow-up)

Primary Outcome Measures

Name	Time	Method
Number of retrospectively recruited CRC cases	6 months	Number of retrospectively recruited CRC cases with complete matched clinical data, radio-imaging data and FFPE or frozen biological samples.

Trial Locations

Locations (13)

IRCCS Istituto Clinico Humanitas; 🇮🇹 Milan, MI, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Institut Català D'Oncologia (ICO); 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain

Ospedale Policlinico San Martino; 🇮🇹 Genova, GE, Italy

Fondazione IRCCS, Istituto Nazionale dei Tumori; 🇮🇹 Milan, MI, Italy

Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, MI, Italy

Istituto Oncologico Veneto (IOV); 🇮🇹 Padua, PD, Italy

Istituto di Candiolo - IRCCS; 🇮🇹 Candiolo, TO, Italy

Azienda Ospedaliero Universitaria San Luigi Gonzaga; 🇮🇹 Orbassano, TO, Italy

Azienda Ospedaliera Ordine Mauriziano; 🇮🇹 Torino, TO, Italy

Hospital del Mar - Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO); 🇪🇸 Barcelona, Spain

INCLIVA - Instituto de Investigatión Sanitaria; 🇪🇸 Valencia, Spain