Colorectal CancerALFAOMEGA-RNCT05101382
A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
An observational study of Colorectal Cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 13 sites in 2 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Observation
- How many people
- 500 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 28 Oct 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: at least 500 colorectal cancer patients at any stage who cannot be reached for an informed consent
Who may be able to join
- 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.
Who cannot join
- if inclusion criteria are not met
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
Italy9 sites, 8 recruiting
- Recruiting
Istituto di Candiolo - IRCCS
Candiolo, TO, 10060
Caterina Marchiò, MD
Caterina Marchiò, MD
- Recruiting
Ospedale Policlinico San Martino
Genova, GE, 16132
Stefania Sciallero, MD
Stefania Sciallero, MD
- Recruiting
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, MI, 20133
Filippo Pietrantonio, MD
Filippo Pietrantonio, MD
- Recruiting
Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
Emanuela Bonoldi, MD
Emanuela Bonoldi, MD
- Recruiting
IRCCS Istituto Clinico Humanitas
Milan, MI
Alberto Puccini, MD
- Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, TO, 10043
Maurizio Degiuli, MD
Maurizio Degiuli, MD
- Recruiting
Istituto Oncologico Veneto (IOV)
Padua, PD, 35128
Sara Lonardi, MD
Sara Lonardi, MD
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56126
Chiara Cremolini, MD
- Active, not recruiting
Azienda Ospedaliera Ordine Mauriziano
Torino, TO, 10128
Spain4 sites, 4 recruiting
- Recruiting
Hospital del Mar - Parc de Salut Mar
Barcelona, 08003
Clara Montagut, MD
Clara Montagut, MD
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, 08035
Elena Élez, MD
Elena Élez, MD
- Recruiting
Institut Català D'Oncologia (ICO)
L'Hospitalet de Llobregat, Barcelona, 08908
Cristina Santos
- Recruiting
INCLIVA - Instituto de Investigatión Sanitaria
Valencia, 46010
Andres Cervantes, MD
Andres Cervantes, MD
About this study
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).
Read the 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.).
- Conditions
- Colorectal Cancer
- Being tested
- Observation
- Keywords
- colorectal cancer, CRC, Gastrointestinal disease
- Medical subject headings
- Colorectal Neoplasms, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Retrospective Observation of standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start28 Oct 2020
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Marsoni, MD, Study director, IFOM ETS - The AIRC Institute of Molecular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101382
- Sponsor's protocol ID
- IFOM-CPO006/2019/PO005
- Acronym
- ALFAOMEGA-R
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
- ClinicalTrials.gov ID
- NCT05101382
- Acronym / sponsor ID
- ALFAOMEGA-R / IFOM-CPO006/2019/PO005
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, CRC, Gastrointestinal disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular OncologyUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of CRC patients | – | Other: ObservationStage-mixed cohort of at least 500 CRC patients that cannot be reached for informed consent (death or lost-to-follow-up) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- at least 500 colorectal cancer patients at any stage who cannot be reached for an informed consent
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- if inclusion criteria are not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationRetrospective Observation of standard clinical practice | Other | Cohort of CRC patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Marsoni, MD study director
IFOM ETS - The AIRC Institute of Molecular Oncology
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Lazzari, PhD (+3902574303799, clinical.trials@ifom.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrospectively recruited CRC cases (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.