Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02906943 |
Other study ID # |
OCTANE |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 2016 |
Est. completion date |
August 2026 |
Study information
Verified date |
November 2023 |
Source |
University Health Network, Toronto |
Contact |
Samanta Del Rossi |
Phone |
416-946-4501 |
Email |
samanta.delrossi[@]uhn.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
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.