Retrospective Observational Study Determining the Clinical Effectiveness of Whole Genome and Transcriptome Analysis to Guide Advanced Cancer Care
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,200
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
This study aims to determine the clinical effectiveness of whole-genome and transcriptome analysis (WGTA) to guide advanced cancer care. The study setting is the British Columbia (BC) Personalized OncoGenomics (POG) program, a single group research study of WGTA guiding treatment planning for patients with advanced, incurable cancers (NCT02155621). To characterize clinical effectiveness, the survival impacts of POG's approach compared to usual care in matched controls will be estimated.
Detailed Description
WGTA provides an opportunity to improve health outcomes for patients by tailoring treatments to each individual's genomic profile. The BC POG Program is a single arm research study integrating WGTA information into clinical decision-making for patients with advanced stage, incurable cancers.The clinical effectiveness of POG's approach is unknown. This retrospective quasi-experimental observational study will estimate the real-world effectiveness of WGTA for guiding advanced cancer care. To identify a counterfactual for POG's single-arm approach, matching methods combined with administrative healthcare data will be used. The survival impacts of POG's approach compared to usual care in matched controls will then be estimated.
Specific Aims and Hypotheses
This study aims to estimate the overall survival effects of POG's approach versus usual care for patients with advanced cancers.
Hypothesis (null): there is no difference in survival across POG and usual care patients
Hypothesis (alternative): POG patients who initiated WGTA live longer, on average, than usual care patients
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 19 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From 1 year up to 4.5 years, adjusted for censoring
Identified from BC Cancer Registry data
Secondary Outcomes
No secondary outcomes reported