Clinical trial NCT05101382: A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
Official title: A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: colorectal cancer
CRC
Gastrointestinal disease
Lead sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: at least 500 colorectal cancer patients at any stage who cannot be reached for an informed consent

Brief 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).

Detailed 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.).

Eligibility criteria: 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

Primary outcomes:
measure: Number of retrospectively recruited CRC cases
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Number of new prognostic and predictive markers
timeFrame: 6 months
measure: Biomarkers correlation with PFS
timeFrame: 6 months
measure: Biomarkers correlation with OS
timeFrame: 6 months
Locations:
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: GE
city: Milan
country: Italy
facility: Fondazione IRCCS, Istituto Nazionale dei Tumori
state: MI
city: Milan
country: Italy
facility: Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
state: MI
city: Milan
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: MI
city: Padua
country: Italy
facility: Istituto Oncologico Veneto (IOV)
state: PD
city: Candiolo
country: Italy
facility: Istituto di Candiolo - IRCCS
state: TO
city: Orbassano
country: Italy
facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga
state: TO
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano
state: TO
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català D'Oncologia (ICO)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO)
city: Valencia
country: Spain
facility: INCLIVA - Instituto de Investigatión Sanitaria
Study officials:
affiliation: IFOM ETS - The AIRC Institute of Molecular Oncology
name: Silvia Marsoni, MD
role: STUDY_DIRECTOR
References: