Personalized medicine

Overview

Evaluate the rapid genomic characterization of patient samples for the “druggable” genome.

Genomics Feasibility Study

Lead Principal investigators:
Clinical Trial Leader – Lillian Siu (University Health Network)
Genomics Platform Leader – John McPherson (OICR Genome Technologies Platform)
Sequenom Platform Leader – Suzanne Kamel-Reid (University Health Network)

Co-applicants:
Janet Dancey, Lincoln Stein, Sangeet Ghai, Pat Shaw

Lead clinical investigators:
Eric Winquist (London), Sebastien Hotte (Hamilton), Glenwood Goss

Objective: to demonstrate a model of rapid genomic characterization of patient samples for the “druggable” genome.

Goals:

  • Demonstrate and optimize the processes and procedures required for assuring adequate specimen collection for sequencing the broad numbers of genes in the cancer genome;
  • Validate the occurrence of “actionable” genetic abnormalities (defined as those having the potential to impact on treatment recommendations for predictive or prognostic reasons, or those with known prognostic or diagnostic implications) in a clinical molecular diagnostics laboratory;
  • Develop the tools to report “actionable” mutations (those that inform medical decisions) to clinicians and patients for treatment or trial recommendations;
  • Develop the databases for clinical, pathological and genomic data collection and integration;
  • Preliminarily assess the comparability of archived diagnostic formalin-fixed paraffin-embedded (FFPE) and fresh tumour biopsy tissues.

Biomarkers to Aid Treatment Decision Making in Early Stage Breast Cancer in Ontario

Lead Principal Investigator:
Mark Levine, McMaster University

Co-applicants:
Dr. John Bartlett, Ontario Institute for Cancer Research
Dr. Murray Krahn, University of Toronto

Objectives:

General Objective
The general objective is to address the overtreatment of early stage breast cancer by identifying a group of good prognosis patients that can be spared adjuvant chemotherapy.

Primary Objective
In patients with ER+ N− breast cancer who are receiving (or will receive) endocrine therapy, to compare the OncotypeDX test, the current standard, with PAM50, Mammostrat and IHC4 tests in identifying those with a low risk of recurrence.

Secondary Objectives
In patients with ER+ N− breast cancer who are receiving (or will receive) endocrine therapy:

1. To compare the OncotypeDX test, the current standard, with PAM50, Mammostrat and IHC4 tests in identifying
those with a high risk of recurrence.

2. To assess the correlation between the biomarker assay quantitative scores (OncotypeDX, Mammostrat, PAM50
and IHC4).

3. To conduct an economic analysis on the utility of the various biomarkers (OncotypeDX, PAM50, Mammostrat and IHC4) to guide the use of adjuvant therapy.