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

NCT ID: NCT05101382

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-28

Study Completion Date

2026-12-31

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.).

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

Observation

Intervention Type OTHER

Retrospective Observation of standard clinical practice

Interventions

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Observation

Retrospective Observation of standard clinical practice

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IFOM ETS - The AIRC Institute of Molecular Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Marsoni, MD

Role: STUDY_DIRECTOR

IFOM ETS - The AIRC Institute of Molecular Oncology

Locations

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Ospedale Policlinico San Martino

Genova, GE, Italy

Site Status RECRUITING

Fondazione IRCCS, Istituto Nazionale dei Tumori

Milan, MI, Italy

Site Status RECRUITING

Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Site Status RECRUITING

IRCCS Istituto Clinico Humanitas

Milan, MI, Italy

Site Status RECRUITING

Istituto Oncologico Veneto (IOV)

Padua, PD, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, Italy

Site Status RECRUITING

Istituto di Candiolo - IRCCS

Candiolo, TO, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria San Luigi Gonzaga

Orbassano, TO, Italy

Site Status RECRUITING

Azienda Ospedaliera Ordine Mauriziano

Torino, TO, Italy

Site Status ACTIVE_NOT_RECRUITING

Institut Català D'Oncologia (ICO)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital del Mar - Parc de Salut Mar

Barcelona, , Spain

Site Status RECRUITING

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, , Spain

Site Status RECRUITING

INCLIVA - Instituto de Investigatión Sanitaria

Valencia, , Spain

Site Status RECRUITING

Countries

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Italy Spain

Central Contacts

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Luca Lazzari, PhD

Role: CONTACT

+3902574303799

Smeralda Rapisarda

Role: CONTACT

+3902574303236

Facility Contacts

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Stefania Sciallero, MD

Role: primary

Filippo Pietrantonio, MD

Role: primary

Emanuela Bonoldi, MD

Role: primary

Sara Lonardi, MD

Role: primary

Caterina Marchiò, MD

Role: primary

Maurizio Degiuli, MD

Role: primary

Clara Montagut, MD

Role: primary

Elena Élez, MD

Role: primary

Andres Cervantes, MD

Role: primary

Other Identifiers

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IFOM-CPO006/2019/PO005

Identifier Type: -

Identifier Source: org_study_id

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