Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

Metastatic Colorectal Cancer Clinical Trial

— FUNNEL  

Official title:

Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03350412
• Other study ID #: 007-IRCC-10IIS-14
• Status: Recruiting
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Massimo Aglietta, md
• Email: massimo.aglietta[@]ircc.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Italy	AOU Policlinico S Orsola - Malpighi	Bologna
Italy	Policlinico S.Orsola Malpighi	Bologna
Italy	Fondazione del Piemonte per l'Oncologia	Candiolo
Italy	IOV - Istituto Oncologico Veneto	Padova
Italy	Policlinico Universitario Campus Biomedico	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thoroughness to report molecular profiling	Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition.	14 days from sample acquisition
Secondary	Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC	number of patients with detected genetic alteration included in the panel (mutations and/or copy number variations) over all recruited patients.	24 months from first patient in.
Secondary	Percentage of complete data capture for treatment-related check-point events		through study completion, an average of five years