Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT03350412
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-22
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-30
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Policlinico Universitario Campus Biomedico; 🇮🇹 Roma, Italy

AOU Policlinico S Orsola - Malpighi; 🇮🇹 Bologna, Italy

Fondazione del Piemonte per l'Oncologia; 🇮🇹 Candiolo, Italy

Policlinico S.Orsola Malpighi; 🇮🇹 Bologna, Italy

IOV - Istituto Oncologico Veneto; 🇮🇹 Padova, Italy