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Personalized Oncogenomics (POG) Program of British Columbia

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ClinicalTrials.gov Identifier: NCT02155621
Recruitment Status : Recruiting
First Posted : June 4, 2014
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
British Columbia Cancer Agency

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 4, 2014
Last Update Posted Date January 28, 2021
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
  • Influence of genomic data on clinical decision-making [ Time Frame: 5 years ]
    This outcome will allow us to study how often in-depth genomic data impacts on clinical decision-making in a general oncology population. It will help describe how useful or important this sort of data is in daily practice.
  • Cataloging of cancer genomes [ Time Frame: 5 years ]
    Accumulation of genomic information linked to treatment/outcome data will greatly enhance our knowledge and understanding of cancers and response to treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Oncogenomics (POG) Program of British Columbia
Official Title  ICMJE Personalized OncoGenomics (POG) Program of British Columbia: Connecting Cancer Genomics to Cancer Care
Brief Summary The genomic heterogeneity of cancers implies that to effectively use targeted therapies the investigators will need to assess each individual cancer and match it to a biologically relevant targeted therapy. The investigators will use full genome sequencing to try to identify cancer "drivers" and corresponding drugs that may inhibit these pathways.
Detailed Description

Carcinogenesis is an immensely complex process such that even within a histologic cancer subtype - for example adenocarcinoma of the lung or breast - there is significant variability in cancer behaviour and response to therapy. Analyses of individual patients demonstrate unique molecular signatures for every cancer examined. Frequently, multiple different pathways are involved in disease growth and progression and the dominant process varies from person to person and perhaps even within different sites of disease within one person. As well these variations evolve in response to treatment.

Recognizing genetic aberrations that promote disease facilitates targeted treatment; this has been demonstrated in several small subgroups of cancers in which specific genetic mutations or translocations have been successfully treated with targeted chemotherapy agents. With many recognized mutations and aberrations, personalized evaluation of the genetic signature encoded in DNA and RNA may provide important diagnostic information and potentially enable directed therapy to the appropriate oncologic pathway thereby providing information to help guide chemotherapy choices

Our initial pilot project demonstrated the feasibility of this approach at our institution (with 100 patients). We now know it is possible to identify and consent patients, sequence the genome and transcriptome, analyze and report abnormalities, and identify potential actionable targets in a clinically relevant time frame.

The Personalized OncoGenomics (POG) program has been operational across the province of BC since 2012. The initial two-year phase established the infrastructure and workflow by which patients with metastatic or incurable cancers could be identified, consented, and biopsied for genomic sequencing in a clinically accredited lab (Laskin et al., 2015). The next phase of the POG program (2014 - 2017) included a strong educational and engagement process such that 83 (80%) of the medical oncologists at BC Cancer were trained to consent and enroll patients onto POG. This means that the oncology community in BC has a broad education in cancer genomics and how these data may be applied to individual patients. Since 2017, the program has been integrated into the Vancouver Cancer Centre's phase 1 clinical trials unit and the focus has shifted to use the study patients and data to address more focused clinical therapeutic trials such as the CCTG CAPTUR study (Skamene et al., 2018). POG-like WGTA has been the driving force behind the creation of the Terry Fox Marathon of Hope Cancer Centre Network (MOHCCN) which is a national program for cancer genomic data sharing across Canada.

The overarching theme of this POG Program is to create a comprehensive cataloguing of somatic cancer mutations and cellular pathway abnormalities that could generate profound insights into genetic patterns that underlie particular cancer phenotypes, and provide valuable prognostic and predictive information.

Eligible subjects will have several samples analyzed: a fresh tumour biopsy (typically 5 cores are required), a blood sample for normal comparison and archival tumours when available. Also, technology has improved such that we may consider using paraffin embedded materials. Comprehensive DNA and RNA sequencing is performed followed by an in-depth bioinformatic analysis to identify somatic mutations, gene expression changes or other abnormalities that might be cancer "drivers" or provide actionable (diagnostic) or druggable targets. The POG team meets every week to discuss the detailed genomic reports for patients, consider additional validation tests when necessary, and debate research questions. The clinicians (typically 5 - 10) come to a consensus on what systemic therapies might be appropriate based on these results. Whenever possible subjects are matched to clinical trials.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Metastatic Cancers
  • Advanced Cancers
  • Cancers That Cannot be Treated With Curative Intent
Intervention  ICMJE Genetic: Genome sequencing
Subjects will have their cancers biopsied and blood samples taken; both will undergo genomic sequencing and analysis
Study Arms  ICMJE Experimental: Genome Sequencing
There is only one arm to this study.
Intervention: Genetic: Genome sequencing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2014)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Patients must agree to allow their archival specimens to be used and possibly completely depleted for these analyses.
  2. Willing and able to have a study-specific biopsy or resection of the tumour or metastatic site OR if there is adequate archival material available, either fresh frozen or FFPE (if specimen is thought to be adequate) that is taken after the most recent chemo or radiation. Ideally this sample should have been collected within 16 weeks of the date of consent. If archival tissue is not adequate and if a biopsy is not feasible or deemed medically safe by the investigators the patient would become ineligible.
  3. Patients must understand and agree to provide a blood test (or other sample of normal DNA) for germline genomic analysis.
  4. ECOG PS 0 or 1.
  5. Age >/= 18 years.
  6. Estimated life expectancy >/= 6 months and high likelihood of being clinically fit for a therapeutic clinical trial in 3-6 months.
  7. Measurable disease with RECIST v1.1 (or updated version).
  8. Adequate organ function.
  9. Patients must clearly understand that this data may be used to help guide treatment recommendations, including the avoidance of some therapeutic agents or the suggestion to use standard cytotoxic chemotherapy agents.
  10. Willingness to have their de-identified genomic and clinical data shared with national and international research collaborators and data sharing platforms (as detailed in the consent form).
  11. Willingness to be contacted for future studies based on the data that is generated by participation in POG; included in this is the anticipation that patient would be fit or a candidate for clinical trials.

Exclusion criteria:

  1. Unable or unwilling to consent to the above tissue and blood requirements.
  2. Significant medical condition that in the opinion of the treating or consenting oncologist and/or the POG central office review team renders the subject not suitable for participation. This includes the likelihood that a subject would be suitable for a clinical trial within 12 weeks after POG biopsy.
  3. Unwilling or unable to provide treatment and outcome follow up information to the BC Cancer or affiliated investigators.
  4. Unwilling to receive medically actionable findings (germline and/or somatic).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janessa J Laskin, MD jlaskin@bccancer.bc.ca
Contact: Marco Marra, PhD mmarra@bcgsc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02155621
Other Study ID Numbers  ICMJE POG 4.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party British Columbia Cancer Agency
Study Sponsor  ICMJE British Columbia Cancer Agency
Collaborators  ICMJE BC Cancer Foundation
Investigators  ICMJE
Principal Investigator: Janessa J Laskin, MD British Columbia Cancer Agency
PRS Account British Columbia Cancer Agency
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP