A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)

Colorectal Cancer Clinical Trial

— ALFAOMEGA-R  

Official title:

A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101382
• Other study ID #: IFOM-CPO006/2019/PO005
• Status: Recruiting
• Start date: October 28, 2020
• Est. completion date: December 2025

Study information

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

Clinical Trial Summary

ALFAOMEGA-RETRÒ will be exploited to retrospectively collect clinical and imaging data and archival samples to be used for validation and correlative studies on markers discovered by cutting-edge translational projects within the AIRC5x1000 program "Insights into the evolving heterogeneity of colorectal cancer (CRC): from mechanism to therapies" (an ongoing multi-institutional research program).

Description:

ALFAOMEGA-RETRÒ, the retrospective "mirror" protocol of ALFAOMEGA (protocol n. IFOM-CPO003/2018/PO002), has been designed to build a retrospective collection of clinically annotated data and biological samples retrieved from colorectal cancer patients (CRC). The repository will feed experimental precision research aimed at i) defining a new taxonomy of CRC based on evolutionary patterns (retrospectively assessed on patient's samples), ii) developing and evaluating innovative biomarker-specific therapeutic strategies derived from or together with ALFAOMEGA. The following data and biological samples will be collected: - Clinical Data (Demographics, Medical History, Cancer Diagnosis & History, Treatment Assessment,). - Imaging Data (CT-Scans, MRI, PET...). - Formalin-Fixed Paraffin-Embedded (FFPE) tissue (either from surgical resections or diagnostic biopsies). - Frozen biological samples (blood, plasma, PBMC, stools, buccal swabs, urines, etc.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically-confirmed diagnosis of colorectal cancer (any stage).
• Age >18 years at the time of diagnosis.
• Availability of clinically-annotated radio-imaging data and/or diagnostic Formalin-Fixed Paraffin Embedded (FFPE) blocks (surgical resections and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
• Verification that the patient could not be reached for informed consent in accordance with applicable national regulations.

Exclusion Criteria:

• if inclusion criteria are not met

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Observation
Retrospective Observation of standard clinical practice

Locations

Country	Name	City	State
Italy	Istituto di Candiolo - IRCCS	Candiolo	TO
Italy	Ospedale Policlinico San Martino	Genova	GE
Italy	Fondazione IRCCS, Istituto Nazionale dei Tumori	Milan	MI
Italy	Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda	Milan	MI
Italy	Azienda Ospedaliero Universitaria San Luigi Gonzaga	Orbassano	TO
Italy	Istituto Oncologico Veneto (IOV)	Padua	PD
Italy	Azienda Ospedaliera Ordine Mauriziano	Torino	TO
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 markers	Number of identified/validated new independent prognostic and predictive biomarkers	6 months
Other	Biomarkers correlation with PFS	Correlation of new prognostic and predictive biomarkers with progression-free survival (PFS).	6 months
Other	Biomarkers correlation with OS	Correlation of new prognostic and predictive biomarkers with overall survival (OS).	6 months
Primary	Number of retrospectively recruited CRC cases	Number of retrospectively recruited CRC cases with complete matched clinical data, radio-imaging data and FFPE or frozen biological samples.	6 months