Colorectal Cancer
Conditions
Keywords
colorectal cancer, CRC, Gastrointestinal disease
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.).
Interventions
OTHERObservation
Retrospective Observation of standard clinical practice
Sponsors
IFOM ETS - The AIRC Institute of Molecular Oncology
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of retrospectively recruited CRC cases | 6 months | Number of retrospectively recruited CRC cases with complete matched clinical data, radio-imaging data and FFPE or frozen biological samples. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of new prognostic and predictive markers | 6 months | Number of identified/validated new independent prognostic and predictive biomarkers |
| Biomarkers correlation with PFS | 6 months | Correlation of new prognostic and predictive biomarkers with progression-free survival (PFS). |
| Biomarkers correlation with OS | 6 months | Correlation of new prognostic and predictive biomarkers with overall survival (OS). |
Countries
Italy, Spain
Contacts
Primary ContactLuca Lazzari, PhD
Backup ContactSmeralda Rapisarda
Outcome results
None listed