Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials (FUNNEL)

Fondazione del Piemonte per l'Oncologia

Status: Unknown

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03350412

007-IRCC-10IIS-14

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.