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NCT Number: NCT05101382

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Policlinico San Martino, Genova, GE, Italy

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About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Retrospective Observation of standard clinical practice

Primary outcomes

  1. Number of retrospectively recruited CRC cases

    Time frame: 6 months

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

Other outcomes

  1. Number of new prognostic and predictive markers

    Time frame: 6 months

    Number of identified/validated new independent prognostic and predictive biomarkers

  2. Biomarkers correlation with PFS

    Time frame: 6 months

    Correlation of new prognostic and predictive biomarkers with progression-free survival (PFS).

  3. Biomarkers correlation with OS

    Time frame: 6 months

    Correlation of new prognostic and predictive biomarkers with overall survival (OS).

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Lazzari, PhD

CONTACT

[email protected]

+3902574303799

Smeralda Rapisarda

CONTACT

[email protected]

+3902574303236

Sponsors and collaborators

Lead sponsor

IFOM ETS - The AIRC Institute of Molecular Oncology

Other

Registry information

Acronym: ALFAOMEGA-R

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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