Ontario-wide Cancer TArgeted Nucleic Acid Evaluation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group
Group A: Advanced cancer

Trial outcomes

Primary outcomes

1

Number of patients included in a province-wide registry of NGS panel-based testing results

Time frame
5 years
2

Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories

Time frame
5 years
3

Number of patients included in province-wide repository of genomically-characterized tumour tissue and blood samples and their utilization rates for future research

Time frame
5 years
4

Change in rates of genomics based clinical research in Ontario

Time frame
5 years

Secondary outcomes

1

Percentage of successful linkages between transferred study data and administrative databases

Time frame
5 years
2

Concordance between administrative data and clinically abstracted data comparing variables using 2x2 concordance tables

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Princess Margaret Hospital, Canada

Collaborator