Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 9:11 PM
Study NCT ID:
NCT04120935
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALFAOMEGA Master Observational Trial
Sponsor:
IFOM ETS - The AIRC Institute of Molecular Oncology
Organization:
Study Overview
Official Title:
A Master Protocol Empowering Precision Research in Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALFAOMEGA
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: