ALFAOMEGA Master Observational Trial

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Observation

• Registration Number: NCT04120935
• Lead Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology

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.

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 Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2019-10-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. TIER1 written Informed consent.
2. Patients ≥18 years of age.
3. Previous diagnosis of colorectal cancer, or a strong suspicion of CRC based on clinical and radiological findings.
4. 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.
5. ECOG Performance status < 2.

Exclusion Criteria

1. 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)
2. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
3. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of CRC patients	Observation	Stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years.

Primary Outcome Measures

Name	Time	Method
Number of patients longitudinally monitored	6 months	1. - Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match.; 2. - Number of recruited CRC cases in TIER2.

Secondary Outcome Measures

Name	Time	Method
Number of patients triaged in proof-of-concept (POC) clinical trials	6 months	Number of CRC cases recruited in TIER3.

Trial Locations

Locations (19)

IRCCS Istituto Clinico Humanitas; 🇮🇹 Milan, MI, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli; 🇮🇹 Napoli, Italy

Hospital Moises Broggi; 🇪🇸 Barcelona, Spain

Fondazione IRCCS, Istituto Nazionale dei Tumori; 🇮🇹 Milan, MI, Italy

Istituto Europeo di Oncologia (IEO); 🇮🇹 Milan, Mi, Italy

Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, MI, Italy

Istituto Oncologico Veneto (IOV); 🇮🇹 Padova, PD, Italy

Istituto di Candiolo - IRCCS; 🇮🇹 Candiolo, Torino, Italy

Azienda Ospedaliero Universitaria San Luigi Gonzaga; 🇮🇹 Orbassano, Torino, Italy

ASL di Biella - Ospedale degli Infermi; 🇮🇹 Biella, Italy

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Perugia, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

AUSL della Romagna - Ospedale Santa Maria delle Croci; 🇮🇹 Ravenna, Italy

Azienda Ospedaliera Ordine Mauriziano; 🇮🇹 Torino, Italy

Hospital del Mar - Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO); 🇪🇸 Barcelona, Spain

Hospital de Sant Joan Despí Moises Broggi; 🇪🇸 Barcelona, Spain

INCLIVA - Instituto de Investigatión Sanitaria; 🇪🇸 Valencia, Spain