ALFAOMEGA Master Observational Trial

Colorectal Cancer Clinical Trial

— ALFAOMEGA  

Official title:

A Master Protocol Empowering Precision Research in Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04120935
• Other study ID #: IFOM-CPO003/2018/PO002
• Status: Recruiting
• Start date: October 15, 2019
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: IFOM ETS - The AIRC Institute of Molecular Oncology
• Contact: Luca Lazzari, PhD
• Phone: +3902574303799
• Email: clinical.trials[@]ifom.eu
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Observation
Prospective Observation of standard clinical practice.

Locations

Country	Name	City	State
Italy	ASL di Biella - Ospedale degli Infermi	Biella
Italy	Istituto di Candiolo - IRCCS	Candiolo	Torino
Italy	Ospedale Policlinico San Martino	Genova
Italy	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	Azienda Ospedaliero Universitaria San Luigi Gonzaga	Orbassano	Torino
Italy	Istituto Oncologico Veneto (IOV)	Padova	PD
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
Spain	Hospital de Sant Joan Despí Moises Broggi	Barcelona
Spain	Hospital del Mar - Parc de Salut Mar	Barcelona
Spain	Vall d'Hebron Institute of Oncology (VHIO)	Barcelona
Spain	INCLIVA - Instituto de Investigatión Sanitaria	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
IFOM ETS - The AIRC Institute of Molecular Oncology

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of new prognostic and predictive biomarkers	- Number of identified/validated new prognostic markers; - Number of identified/validated new predictive markers.	6 months
Other	Correlation of new prognostic and predictive biomarkers with clinical outcomes	- Correlation between identified biomarkers with therapies response rates (RR).; - Correlation between identified biomarkers with progression-free survival (PFS).; - Correlation between identified biomarkers with overall survival (OS).	6 months
Primary	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.	6 months
Secondary	Number of patients triaged in proof-of-concept (POC) clinical trials	Number of CRC cases recruited in TIER3.	6 months