Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

NCT03350412 | Unknown

• 1 other identifier: 007-IRCC-10IIS-14
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC

  24 months from first patient in.

• Percentage of complete data capture for treatment-related check-point events

  through study completion, an average of five years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

FUNNEL population consists of individual at least 18 years of age with newly diagnosed metastatic colorectal carcinoma at the first sign of metastasis (adjuvant relapse or first diagnosis)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (5)

AOU Policlinico S Orsola - Malpighi

Bologna, Italy

RECRUITING

Policlinico S.Orsola Malpighi

Bologna, Italy

RECRUITING

Fondazione del Piemonte per l'Oncologia

Candiolo, 10060, Italy

RECRUITING

IOV - Istituto Oncologico Veneto

Padua, Italy

RECRUITING

Policlinico Universitario Campus Biomedico

Roma, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumor specimens

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Massimo Aglietta, md

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Aglietta, md

CONTACT

massimo.aglietta@ircc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: November 22, 2017
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

IT (5)