ALFAOMEGA Master Observational Trial
ALFAOMEGA
A Master Protocol Empowering Precision Research in Colorectal Cancer
1 other identifier
observational
3,000
2 countries
19
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
August 24, 2025
August 1, 2025
6.6 years
September 18, 2019
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients longitudinally monitored
1. \- Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match. 2. \- Number of recruited CRC cases in TIER2.
6 months
Secondary Outcomes (1)
Number of patients triaged in proof-of-concept (POC) clinical trials
6 months
Other Outcomes (2)
Number of new prognostic and predictive biomarkers
6 months
Correlation of new prognostic and predictive biomarkers with clinical outcomes
6 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Colorectal cancer patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
ASL di Biella - Ospedale degli Infermi
Biella, Biella, 13875, Italy
IRCCS Istituto Clinico Humanitas
Milan, MI, 20089, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, MI, 20133, Italy
Istituto Europeo di Oncologia (IEO)
Milan, Mi, 20141, Italy
Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162, Italy
Istituto Oncologico Veneto (IOV)
Padua, PD, 35128, Italy
Ospedale Santa Maria della Misericordia
Perugia, Perugia, 06129, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56126, Italy
AUSL della Romagna - Ospedale Santa Maria delle Croci
Ravenna, Ravenna, 48121, Italy
Istituto di Candiolo - IRCCS
Candiolo, Torino, 10060, Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Ospedale Policlinico San Martino
Genova, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Napoli, 80131, Italy
Azienda Ospedaliera Ordine Mauriziano
Torino, Italy
Hospital de Sant Joan Despí Moises Broggi
Barcelona, Barcelona, 08970, Spain
Hospital del Mar - Parc de Salut Mar
Barcelona, Spain, 08003, Spain
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 08035, Spain
INCLIVA - Instituto de Investigatión Sanitaria
Valencia, Spain, 46010, Spain
Hospital Moises Broggi
Barcelona, 08970, Spain
Biospecimen
* FFPE Tissue * Fresh Tissue (tumor and normal) * Plasma * PBMC * Whole Blood * Stools * Buccal Swabs
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Marsoni, MD
IFOM ETS - The AIRC Institute of Molecular Oncology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2019
First Posted
October 9, 2019
Study Start
October 15, 2019
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
August 24, 2025
Record last verified: 2025-08