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Ontario-wide Cancer TArgeted Nucleic Acid Evaluation (OCTANE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02906943
First received: September 9, 2016
Last updated: August 1, 2017
Last verified: August 2017
  Purpose

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.


Condition
Breast Cancer Lung Cancer Colorectal Cancer Melanoma Gynecological Cancer Genitourinary Cancer Pancreatobiliary Cancer Gastrointestinal Cancer Head and Neck Cancer Rare Cancer Unknown Primary Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ontario-wide Cancer TArgeted Nucleic Acid Evaluation

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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

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

Biospecimen Retention:   Samples With DNA
Archival tumor tissue 2 tubes of whole blood

Estimated Enrollment: 10000
Study Start Date: August 2016
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02906943

Contacts
Contact: Lailah Ahmed 416-946-4501 ext 3638 lailah.ahmed@uhn.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada
Contact: Elisa Shore    905-387-9711 ext 67135    shore@hhsc.ca   
Principal Investigator: Sébastien Hotte, MD         
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Contact: Jessica Ferguson    613-549-6666 ext 7231    fergusj2@kgh.kari.net   
Contact: Carrie Hartman    613-549-6666 ext 7221    hartmanc@KGH.KARI.NET   
Principal Investigator: Andrew Robinson, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Lee-Anne Pickard    519-685-8500 ext 56605    LeeAnne.Pickard@lhsc.on.ca   
Principal Investigator: Stephen Welch, MD         
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada
Contact: Elina Iordanidi    613-737-7700 ext 73378    eiordanidi@ohri.ca   
Contact: Nancy Drummond-Ivars       ndrummond@toh.ca   
Principal Investigator: John Hilton, MD         
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Catherine Ho    416-946-4501 ext 3486    catherine.ho@uhn.ca   
Principal Investigator: Philippe Bedard, MD         
Principal Investigator: Lillian Siu, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Philippe Bedard, MD Princess Margaret Hospital, Canada
Principal Investigator: Lillian Siu, MD Princess Margaret Hospital, Canada
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02906943     History of Changes
Other Study ID Numbers: OCTANE
Study First Received: September 9, 2016
Last Updated: August 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.


Keywords provided by University Health Network, Toronto:
Molecular Profiling
Advanced Cancer
Advanced Solid Tumors
Phase I Clinical Trial Candidates
Next Generation Sequencing

Additional relevant MeSH terms:
Colorectal Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Urogenital Neoplasms
Neoplasms, Unknown Primary
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2017