Collecting data and samples from colorectal cancer patients for precision research

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

This study is collecting health information and samples from colorectal cancer patients to see how it can help create better, personalized treatments for the disease.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology (Academic / other)
• Locations: 13 sites (Genova, GE and 12 other locations)
• Trial ID: NCT05101382 on ClinicalTrials.gov

What this trial studies

ALFAOMEGA-RETRÒ is designed to retrospectively gather clinical and imaging data, along with biological samples from colorectal cancer patients. This observational study aims to create a repository that will support precision research by validating and correlating findings from ongoing translational projects. The collected data will help define a new taxonomy of colorectal cancer based on evolutionary patterns and develop innovative biomarker-specific therapeutic strategies. The study will utilize various clinical and imaging data, as well as formalin-fixed and frozen biological samples.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with a histologically-confirmed diagnosis of colorectal cancer and available clinical and imaging data.

Not a fit: Patients who do not have the required clinical data or biological samples, or those who do not meet the inclusion criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to more personalized and effective treatment strategies for colorectal cancer patients.

How similar studies have performed: Other studies focusing on precision medicine in colorectal cancer have shown promise, indicating that this approach could be beneficial.

Eligibility criteria

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

Where this trial is running

Genova, GE and 12 other locations

• Ospedale Policlinico San Martino — Genova, Ge, Italy (Recruiting)
• Fondazione IRCCS, Istituto Nazionale dei Tumori — Milan, Mi, Italy (Recruiting)
• Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda — Milan, Mi, Italy (Recruiting)
• IRCCS Istituto Clinico Humanitas — Milan, Mi, Italy (Recruiting)
• Istituto Oncologico Veneto (IOV) — Padua, Pd, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Pisana — Pisa, Pisa, Italy (Recruiting)
• Istituto di Candiolo - IRCCS — Candiolo, To, Italy (Recruiting)
• Azienda Ospedaliero Universitaria San Luigi Gonzaga — Orbassano, To, Italy (Recruiting)
• Azienda Ospedaliera Ordine Mauriziano — Torino, To, Italy (Active_not_recruiting)
• Institut Català D'Oncologia (ICO) — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
• Hospital del Mar - Parc de Salut Mar — Barcelona, Spain (Recruiting)
• Vall d'Hebron Institute of Oncology (VHIO) — Barcelona, Spain (Recruiting)
• INCLIVA - Instituto de Investigatión Sanitaria — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Luca Lazzari, PhD

Conditions Colorectal Cancer; colorectal cancer; CRC; Gastrointestinal disease