A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.).
Interventions
- Other Observation
Retrospective Observation of standard clinical practice
Primary outcome measures
- Number of retrospectively recruited CRC cases [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 9 centers
- Ospedale Policlinico San Martino — Genova
- Fondazione IRCCS, Istituto Nazionale dei Tumori — Milan
- Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda — Milan
- IRCCS Istituto Clinico Humanitas — Milan
- Istituto Oncologico Veneto (IOV) — Padua
- Azienda Ospedaliero Universitaria Pisana — Pisa
- Istituto di Candiolo - IRCCS — Candiolo
- Azienda Ospedaliero Universitaria San Luigi Gonzaga — Orbassano
- … and 1 more center
Spain · 4 centers
- Institut Català D'Oncologia (ICO) — L'Hospitalet de Llobregat
- Hospital del Mar - Parc de Salut Mar — Barcelona
- Vall d'Hebron Institute of Oncology (VHIO) — Barcelona
- INCLIVA - Instituto de Investigatión Sanitaria — Valencia
Identifiers
NCT: NCT05101382 · IFOM-CPO006/2019/PO005