Metastatic Colorectal Cancer
Conditions
Brief summary
The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.
Interventions
None listed
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery. * Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital. * Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year. * Age ≥18. * ECOG PS 0-1. * No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial. * Signed informed consent.
Exclusion criteria
* Symptomatic brain metastases. * Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption. * History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years. * No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thoroughness to report molecular profiling | 14 days from sample acquisition | Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC | 24 months from first patient in. | number of patients with detected genetic alteration included in the panel (mutations and/or copy number variations) over all recruited patients. |
| Percentage of complete data capture for treatment-related check-point events | through study completion, an average of five years | — |
Countries
Italy
Contacts
Primary ContactMassimo Aglietta, md
Outcome results
None listed