Colorectal CancerALFAOMEGANCT04120935
ALFAOMEGA Master Observational Trial
An observational study of Colorectal Cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 19 sites in 2 countries.
Trial summary
AlfaOmega has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improval). 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
- 3,000 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 15 Oct 2019to 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
- Adult, Older adult
Study population: Colorectal cancer patients
Who may be able to join
- TIER1 written Informed consent.
- Patients ≥18 years of age.
- Previous diagnosis of colorectal cancer, or a strong suspicion of CRC based on clinical and radiological findings.
- In patients with previous diagnosis of CRC availability of diagnostic Formalin-Fixed, Paraffin Embedded (FFPE) blocks (surgical resection and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
- ECOG Performance status < 2.
Who cannot join
- Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
Italy14 sites, 13 recruiting
- Recruiting
ASL di Biella - Ospedale degli Infermi
Biella, Biella, 13875
Francesco Leone, MD
- Recruiting
Istituto di Candiolo - IRCCS
Candiolo, Torino, 10060
Elisabetta Fenocchio, MD
- Recruiting
Ospedale Policlinico San Martino
Genova
Stefania Sciallero, MD
- Recruiting
IRCCS Istituto Clinico Humanitas
Milan, MI, 20089
Alberto Puccini, MD
- Recruiting
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, MI, 20133
Filippo Pietrantonio, MD
- Recruiting
Istituto Europeo di Oncologia (IEO)
Milan, Mi, 20141
Maria Giulia Zampino, MD
- Recruiting
Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162
Salvatore Siena, MD
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, 80131
Teresa Troiani, MD
- Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, Torino
Maurizio Degiuli, MD
- Recruiting
Istituto Oncologico Veneto (IOV)
Padova, PD, 35128
Sara Lonardi, MD
- Recruiting
Ospedale Santa Maria della Misericordia
Perugia, Perugia, 06129
Mario Mandalà, MD
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56126
Chiara Cremolini, MD
- Recruiting
AUSL della Romagna - Ospedale Santa Maria delle Croci
Ravenna, Ravenna, 48121
Stefano Tamberi, MD
- Active, not recruiting
Azienda Ospedaliera Ordine Mauriziano
Torino
Spain5 sites, 5 recruiting
- Recruiting
Hospital de Sant Joan Despí Moises Broggi
Barcelona, Barcelona, 08970
Cristina Vivas, MD
- Recruiting
Hospital del Mar - Parc de Salut Mar
Barcelona, Spain, 08003
Clara Montagut, MD
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 08035
Josep Tabernero, MD
- Recruiting
Hospital Moises Broggi
Barcelona, 08970
Cristina Santos
- Recruiting
INCLIVA - Instituto de Investigatión Sanitaria
Valencia, Spain, 46010
Andrés Cervantes, MD
About this study
Official title: A Master Protocol Empowering Precision Research in Colorectal Cancer
AlfaOmega has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improval). This clinical resource for integrative clinical data and sample collection will allow the molecular story-telling of CRC metastatic spread along time and space and the selection of appropriate patients for experimentally-driven trials.
Read the detailed description
AlfaOmega is an observational study that will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, AlphaOmega will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials. To achieve the required level of 'experimental precision', patients will enter AlphaOmega at two different 'therapeutic checkpoints': i) prior to a surgical event or ii) prior to a systemic treatment. In the latter case patients with no previous lines of therapy for metastatic disease will be privileged.
To optimize the enrollment of patients, the longitudinal collection of data/samples and their logistic management, AlphaOmega has been designed as a flexible infrastructure organized in TIERS for the stepwise comprehension of the biological processes that drive tumor evolution, and precisely:
- TIER1, Monitoring: the ability to follow CRC evolution under standard of care treatments and to define new evolution-linked biomarkers. This will be achieved through the collection of clinical data, imaging data, FFPE tissue and frozen plasma/PBMC.
- TIER2, Modelling: the ability to develop pertinent experimental models to study evolutionary mechanisms and define evolution-targeting therapeutic strategies. This will be achieved through the collection of Fresh Tissue, Whole Blood, Stools, Buccal Swabs and other fluids.
- TIER3, Linking: the ability to access data and samples of patients enrolled in proof-of-concept trials to prove the efficacy and study/understand resistance mechanisms of evolution-targeting therapies. This will be achieved by introducing the connection in the trial protocol.
- Conditions
- Colorectal Cancer
- Being tested
- Observation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Prospective Observation of standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of CRC patients | Stage-mixed cohort of at least 3000 patients through their course of treatments, until death or a minimum of 5 years. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients longitudinally monitored
- - Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match.
- - Number of recruited CRC cases in TIER2.
Measured: 6 months
Secondary outcomes (1)
Number of patients triaged in proof-of-concept (POC) clinical trials
Number of CRC cases recruited in TIER3.
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 posted9 Oct 2019
- Study start15 Oct 2019
- 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
- Prospective
- Enrolment
- 3,000 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, Principal investigator, IFOM ETS - The AIRC Institute of Molecular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120935
- Sponsor's protocol ID
- IFOM-CPO003/2018/PO002
- Acronym
- ALFAOMEGA
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2019
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Master Protocol Empowering Precision Research in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04120935
- Acronym / sponsor ID
- ALFAOMEGA / IFOM-CPO003/2018/PO002
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular OncologyUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Oct 2019 (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 has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improval). This clinical resource for integrative clinical data and sample collection will allow the molecular story-telling of CRC metastatic spread along time and space and the selection of appropriate patients for experimentally-driven trials.
Detailed description
AlfaOmega is an observational study that will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, AlphaOmega will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials. To achieve the required level of 'experimental precision', patients will enter AlphaOmega at two different 'therapeutic checkpoints': i) prior to a surgical event or ii) prior to a systemic treatment. In the latter case patients with no previous lines of therapy for metastatic disease will be privileged.
To optimize the enrollment of patients, the longitudinal collection of data/samples and their logistic management, AlphaOmega has been designed as a flexible infrastructure organized in TIERS for the stepwise comprehension of the biological processes that drive tumor evolution, and precisely:
- TIER1, Monitoring: the ability to follow CRC evolution under standard of care treatments and to define new evolution-linked biomarkers. This will be achieved through the collection of clinical data, imaging data, FFPE tissue and frozen plasma/PBMC.
- TIER2, Modelling: the ability to develop pertinent experimental models to study evolutionary mechanisms and define evolution-targeting therapeutic strategies. This will be achieved through the collection of Fresh Tissue, Whole Blood, Stools, Buccal Swabs and other fluids.
- TIER3, Linking: the ability to access data and samples of patients enrolled in proof-of-concept trials to prove the efficacy and study/understand resistance mechanisms of evolution-targeting therapies. This will be achieved by introducing the connection in the trial protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of CRC patients | – | Other: ObservationStage-mixed cohort of at least 3000 patients through their course of treatments, until death or a minimum of 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients
Key inclusion criteria (5 listed)
- TIER1 written Informed consent.
- Patients ≥18 years of age.
- Previous diagnosis of colorectal cancer, or a strong suspicion of CRC based on clinical and radiological findings.
- In patients with previous diagnosis of CRC availability of diagnostic Formalin-Fixed, Paraffin Embedded (FFPE) blocks (surgical resection and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
- ECOG Performance status < 2.
Key exclusion criteria (3 listed)
- Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
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 |
|---|---|---|
| ObservationProspective Observation of standard clinical practice. | Other | Cohort of CRC patients |
Primary outcome
Number of patients longitudinally monitored
Time frame: 6 months
1. - Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match. 2. - Number of recruited CRC cases in TIER2.
1 secondary outcome
Number of patients triaged in proof-of-concept (POC) clinical trials
Time frame: 6 months
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
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Not yet recruitingPhase 2
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
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 principal investigator
IFOM ETS - The AIRC Institute of Molecular Oncology
19 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 19 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 5 inclusion and 3 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 19 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 patients longitudinally monitored (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.