Ontario-wide Cancer TArgeted Nucleic Acid Evaluation (OCTANE)

November 29, 2023 updated by: University Health Network, Toronto

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

A recent survey of clinical genetic testing laboratories for cancer diagnostics by the Molecular Oncology Advisory Committee for Cancer Care Ontario identified disparities in access and use patterns for next generation sequencing (NGS) across the province of Ontario. All fourteen responding laboratories indicated that NGS instruments were either currently being used for clinical testing, were in the validation stage, or that they were planning to purchase NGS instruments within the near future. Respondents were uncertain about what tests should be performed, how costing and reimbursement would be addressed by the provincial funding agency (e.g. individual tests vs. panels), and how to deal with informatics issues from NGS testing, such as storage, variant interpretation, and utilization over the long term.

Given the increasing use of multi-gene somatic mutation testing in routine clinical cancer care (e.g. KRAS, NRAS, BRAF mutations in colorectal cancer, EGFR mutation and ALK translocation in non-small cell lung cancer, and BRAF, NRAS, and cKIT mutations in malignant melanoma), there is a need to expand the infrastructure for NGS panel testing in clinical laboratories. With a single payer provincial health care system, there is also an opportunity to develop a provincial-wide registry of NGS panel-based testing results and repository of genomically-characterized and clinically-annotated tumor tissues and blood samples to accelerate the development of additional "omic"-based tests for clinical use.

This study will enroll patients with advanced, incurable solid tumors at selected Ontario hospitals receiving standard palliative treatment(s). Archival formalin-fixed paraffin embedded (FFPE) tumor tissue will be requested and undergo targeted panel sequencing. An additional FFPE tissue sample will be requested at the same time for future research purposes. Patients will also be asked to provide blood samples for future research. A selected number of genes will be annotated in a research report provided to their treating oncologist. In addition to the clinically reported variants, targeted NGS testing results for all tested genes will be captured in a clinical research database that can be accessed by the treating oncologist in a secure web-based portal.

Following the reporting of targeted DNA sequencing results into the web-portal, remaining tumor DNA will be stored in the clinical testing laboratories. Blood samples collected at the time of consent and additional FFPE research blocks or slides collected for research will be transferred to a centralized biorepository maintained by the Ontario Tumour Bank (OTB) for more comprehensive analysis at the Princess Margaret (PM)-Ontario Institute for Cancer Research (OICR) Translational Genomics Laboratory (TGL). Blood will undergo standard germline DNA extraction and plasma processing for future circulating tumor DNA (ctDNA) and RNA (ctRNA) isolation at the PM-OICR TGL. Selected patient samples will be further characterized at the PM-OICR TGL for test development, additional sequencing, or discovery research.

All patients will be asked to provide permission for data-sharing with other cancer researchers. The consent will also include a provision for review of patient health records through review of patient charts or administrative databases (i.e. Cancer Care Ontario New Drug Funding Program, Provincial Cancer Registry, etc.) to obtain addition information about time on drug treatments and survival.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Active, not recruiting
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada
        • Active, not recruiting
        • Kingston General Hospital
      • London, Ontario, Canada
        • Active, not recruiting
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital Cancer Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Hilton, MD
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Lillian Siu, MD
        • Principal Investigator:
          • Philippe Bedard, MD
      • Toronto, Ontario, Canada
        • Active, not recruiting
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • Active, not recruiting
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Advanced solid tumor malignancies, where archived formalin-fixed paraffin embedded (FFPE) is available and adequate for molecular profiling.

Description

Inclusion Criteria:

  1. Patients with histological confirmation of advanced solid tumor malignancies who are candidates for systemic therapy.
  2. All patients must have sufficient FFPE archived tumor tissue for molecular profiling.
  3. Patient must be ≥ 18 years old.
  4. Patient's ECOG performance status equal to 0 or 1.
  5. All patients must have a life expectancy of > 6 months.
  6. All patients must have adequate organ functions.
  7. All patients must have signed and dated an informed consent form.

Exclusion Criteria:

1. Patients must not have received more than 2 lines of prior cytotoxic therapy for their recurrent/metastatic disease, with the exception of Phase I trial candidates who will not be excluded if more than 2 lines of prior cytotoxic therapy have been received.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Advanced cancer
Patients with advanced, incurable solid tumors receiving standard palliative treatment(s) will have archival tumor specimens requested and used for targeted next generation sequencing (NGS) testing. Blood samples and additional archival tumor specimens will be collected for banking and future research purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients included in a province-wide registry of NGS panel-based testing results
Time Frame: 5 years
5 years
Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories
Time Frame: 5 years
5 years
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
5 years
Change in rates of genomics based clinical research in Ontario
Time Frame: 5 years
5 years
Utilization rates of province-wide genomically-characterized and clinically-annotated patient base in enrollment into specific research initiatives
Time Frame: 5 years
5 years
Utilization rates of molecular profiling information provided to treating physicians in guiding future treatment decisions
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of successful linkages between transferred study data and administrative databases
Time Frame: 5 years
5 years
Concordance between administrative data and clinically abstracted data comparing variables using 2x2 concordance tables
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Lillian Siu, MD, Princess Margaret Hospital, Canada
  • Principal Investigator: Philippe Bedard, MD, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimated)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCTANE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Targeted gene sequencing results, along with limited clinical information that does not identify the patient as an individual, such as age, partial date of birth (year, month), gender, cancer type, and pathology information related to the samples tested, and survival time will be sent to centralized scientific databases or shared with collaborating researchers.

Data from this study can be shared through two types of databases: open-access or controlled-access. An open-access database is publicly accessible and contains limited clinical information and analyses of samples. A controlled-access database contains more detailed clinical information, such as relevant past medical history and the results of prior and ongoing cancer treatments, and analyses of samples, but is only accessible to researchers who sign agreements defining how data may be used. All data will be stripped of all personal identifying information.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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