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

NCT05101382 | Recruiting

• 1 other identifier: IFOM-CPO006/2019/PO005
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 13

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).

Conditions

Colorectal Cancer

Keywords

colorectal cancer; CRC; Gastrointestinal disease

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (3)

• Number of new prognostic and predictive markers

  6 months

• Biomarkers correlation with PFS

  6 months

• Biomarkers correlation with OS

  6 months

Study Arms (1)

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)

Other: Observation

Interventions

Observation OTHER

Retrospective Observation of standard clinical practice

Cohort of CRC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

at least 500 colorectal cancer patients at any stage who cannot be reached for an informed consent

You may qualify if:

• 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.

Sponsors & Collaborators

• IFOM ETS - The AIRC Institute of Molecular Oncology: lead

Study Sites (13)

Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

RECRUITING

Fondazione IRCCS, Istituto Nazionale dei Tumori

Milan, MI, 20133, Italy

RECRUITING

Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Milan, MI, Italy

RECRUITING

Istituto Oncologico Veneto (IOV)

Padua, PD, 35128, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

Istituto di Candiolo - IRCCS

Candiolo, TO, 10060, Italy

RECRUITING

Azienda Ospedaliero Universitaria San Luigi Gonzaga

Orbassano, TO, 10043, Italy

RECRUITING

Azienda Ospedaliera Ordine Mauriziano

Torino, TO, 10128, Italy

ACTIVE NOT RECRUITING

Institut Català D'Oncologia (ICO)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

RECRUITING

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, 08035, Spain

RECRUITING

INCLIVA - Instituto de Investigatión Sanitaria

Valencia, 46010, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

FFPE tissue Frozen biological samples (whole blood, plasma, PBMC, stools, buccal swabs, urines)

MeSH Terms

Conditions

Colorectal Neoplasms; Gastrointestinal Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Silvia Marsoni, MD

  IFOM ETS - The AIRC Institute of Molecular Oncology

  STUDY DIRECTOR

Central Study Contacts

Luca Lazzari, PhD

CONTACT

+3902574303799; clinical.trials@ifom.eu

Smeralda Rapisarda

CONTACT

+3902574303236; clinical.trials@ifom.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: October 28, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

IT (9); ES (4)