About this trial
Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.
Biomarkers are specific characteristics of the cancer that may help provide prognostic information (e.g. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.
The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, which may help their physicians to identify which clinical trials of new drug treatments may be most appropriate for the patient in the future and may also guide the use of approved treatments that may potentially benefit the patient.
Another goal of this study is to develop a province-wide registry of targeted gene sequencing testing results that will be made available to cancer researchers. Additional tumour tissue and blood samples collected from all study participants will also be stored in a biobank at the Ontario Institute for Cancer Research for future research.
The study will also look at linking data from this study to other health care databases to further collect information about the health care the patients received, including medical tests, clinic visits, or procedures both before and after participating in this study. Having more information about patient health to relate to the DNA sequences may provide new insights into cancer and its treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histological confirmation of advanced solid tumor malignancies who are candidates for systemic therapy.
All patients must have sufficient FFPE archived tumor tissue for molecular profiling.
Patient must be ≥ 18 years old.
Patient's ECOG performance status equal to 0 or 1.
Disqualifiers
None
Trial population
Advanced solid tumor malignancies, where archived formalin-fixed paraffin embedded (FFPE) is available and adequate for molecular profiling.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of patients included in a province-wide registry of NGS panel-based testing results
Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories
Number of patients included in province-wide repository of genomically-characterized tumour tissue and blood samples and their utilization rates for future research
Change in rates of genomics based clinical research in Ontario
Secondary outcomes
Percentage of successful linkages between transferred study data and administrative databases
Concordance between administrative data and clinically abstracted data comparing variables using 2x2 concordance tables
Sponsors and contacts
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University Health Network, Toronto
Lead sponsor
Princess Margaret Hospital, Canada
Collaborator