Metastatic CancerNCT04141397
Real-world Clinical Effectiveness of Whole Genome and Transcriptome Analysis to Guide Advanced Cancer Care
An observational study of Metastatic Cancer and Advanced Cancer, run by British Columbia Cancer Agency.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Metastatic Cancer, Advanced Cancer, Cancers That Cannot be Treated With Curative Intent
- What is being tested?
- Initiation of POG-related WGTA
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: BC Cancer administrative data will be used to identify adult patients diagnosed with cancer and residing in BC during the study period who either: 1. Had advanced, incurable cancer and enrolled in the BC Cancer POG Program OR 2. Whose prior staging information, healthcare utilization and/or treatment history indicated they had advanced cancers and who were matched on a baseline covariates at their date of metastatic disease diagnosis.
Who may be able to join
- BC residency
- Metastatic disease considered incurable by their treating oncologist
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Consented to POG and undergone initial biopsy between July 2014 and December 2017
- Diagnosed with cancer prior to December 2017
Show all 9Show fewer
- BC residents during study period
- Received care at BC Cancer during study period
- Alive July 1st 2014
Who cannot join
- BC Medical Services Plan personal health number missing or invalid
- Cancer case diagnosed at death
- Age at diagnosis ≤18
About this study
Official title: Retrospective Observational Study Determining the Clinical Effectiveness of Whole Genome and Transcriptome Analysis to Guide Advanced Cancer Care
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.
Read the 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
This study will apply a retrospective cohort design. Cohorts will include patients who consented to POG and underwent a biopsy for WGTA between July 2014 and December 2017 and matched usual care controls. POG patients who enrolled prior to July 2014 will be excluded from our study because during this feasibility period, referring clinicians employed a high level of case-by-case recruitment selection. Usual care patients will be matched to POG patients using supervised learning techniques. The study period will range from patient's time of metastatic cancer diagnosis to December 31 2018.
Data Sources
De-identified linked population-based administrative datasets will be obtained from BC Cancer for all adult patients (>18 years) diagnosed with cancers in BC prior to December 2017. POG patients will be identified from the BC Cancer Outcomes and Surveillance Integration System (OaSIS) POG Module Database. Eligible control patients will be identified from the BC Cancer Registry, a population-based provincial cancer registry. These data will be linked with data from the BC Cancer Pharmacy Database, Radiotherapy Database, and Cancer Agency Information System (CAIS) using agency-specific identifiers.
Statistical Approach
The investigators will match POG patients and usual care patients based on their date of metastatic disease diagnosis. They will apply 1:1 genetic algorithm-based matching (1:2 in sensitivity analysis) and match patients on propensity scores and baseline covariates, including patient demographics, clinical characteristics, treatment histories, and healthcare utilization prior to metastatic disease diagnosis. When necessary, matching analyses will be stratified to account for variation across cancer types.
To estimate overall survival in POG patients and matched controls, non-parametric and parametric survival analyses will be used. These analyses will be adjusted for censoring. The investigators will explore heterogeneity in clinical effectiveness across cancer subtypes through subgroup analysis and use scenario analysis to determine the impact of future changes in the application of WGTA on clinical effectiveness.
- Being tested
- Initiation of POG-related WGTA, Usual care
- Keywords
- precision medicine, genomic sequencing, administrative data, quasi-experimental methods, matching, clinical effectiveness
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of POG-related WGTAGenetic
POG-related WGTA generally involves collecting biopsy samples, applying whole-genome and transcriptome sequencing, and using bioinformatics analysis to interpret sequence data and inform clinical decision-making.
Usual careGenetic
Usual care, not involving the initiation of POG-related WGTA
| Study group | Role | What they receive |
|---|---|---|
| POG patients | Patients enrolled in POG who initiated WGTA between July 2014 and December 2017 Receives: Genetic: Initiation of POG-related WGTA | |
| Usual care controls | Matched controls who received usual care and were diagnosed with metastatic cancer prior to December 2017 Receives: Genetic: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Identified from BC Cancer Registry data
Measured: From 1 year up to 4.5 years, adjusted for censoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jul 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- BC Cancer Foundation, Genome British Columbia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141397
- Sponsor's protocol ID
- POG Clinical Effectiveness
- Status last verified
- Jan 2021
- First submitted
- 23 Oct 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient-level administrative data used in this retrospective study are confidential and will not be made available in a public repository, in accordance with institutional policies.
Publications
Laskin J, Jones S, Aparicio S, Chia S, Ch'ng C, Deyell R, Eirew P, Fok A, Gelmon K, Ho C, Huntsman D, Jones M, Kasaian K, Karsan A, Leelakumari S, Li Y, Lim H, Ma Y, Mar C, Martin M, Moore R, Mungall A, Mungall K, Pleasance E, Rassekh SR, Renouf D, Shen Y, Schein J, Schrader K, Sun S, Tinker A, Zhao E, Yip S, Marra MA. Lessons learned from the application of whole-genome analysis to the treatment of patients with advanced cancers. Cold Spring Harb Mol Case Stud. 2015 Oct;1(1):a000570. doi: 10.1101/mcs.a000570.
PubMed 27148575Diamond A, Sekhon JS. Genetic matching for estimating causal effects: A general multivariate matching method for achieving balance in observational studies. Review of Economics and Statistics. 95(3):932-945, 2013.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study Determining the Clinical Effectiveness of Whole Genome and Transcriptome Analysis to Guide Advanced Cancer Care
- ClinicalTrials.gov ID
- NCT04141397
- Acronym / sponsor ID
- POG Clinical Effectiveness
- Keywords
- precision medicine, genomic sequencing, administrative data, quasi-experimental methods, matching, clinical effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- BC Cancer Foundation, Genome British Columbia
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
This study will apply a retrospective cohort design. Cohorts will include patients who consented to POG and underwent a biopsy for WGTA between July 2014 and December 2017 and matched usual care controls. POG patients who enrolled prior to July 2014 will be excluded from our study because during this feasibility period, referring clinicians employed a high level of case-by-case recruitment selection. Usual care patients will be matched to POG patients using supervised learning techniques. The study period will range from patient's time of metastatic cancer diagnosis to December 31 2018.
Data Sources
De-identified linked population-based administrative datasets will be obtained from BC Cancer for all adult patients (>18 years) diagnosed with cancers in BC prior to December 2017. POG patients will be identified from the BC Cancer Outcomes and Surveillance Integration System (OaSIS) POG Module Database. Eligible control patients will be identified from the BC Cancer Registry, a population-based provincial cancer registry. These data will be linked with data from the BC Cancer Pharmacy Database, Radiotherapy Database, and Cancer Agency Information System (CAIS) using agency-specific identifiers.
Statistical Approach
The investigators will match POG patients and usual care patients based on their date of metastatic disease diagnosis. They will apply 1:1 genetic algorithm-based matching (1:2 in sensitivity analysis) and match patients on propensity scores and baseline covariates, including patient demographics, clinical characteristics, treatment histories, and healthcare utilization prior to metastatic disease diagnosis. When necessary, matching analyses will be stratified to account for variation across cancer types.
To estimate overall survival in POG patients and matched controls, non-parametric and parametric survival analyses will be used. These analyses will be adjusted for censoring. The investigators will explore heterogeneity in clinical effectiveness across cancer subtypes through subgroup analysis and use scenario analysis to determine the impact of future changes in the application of WGTA on clinical effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POG patients | – | Genetic: Initiation of POG-related WGTAPatients enrolled in POG who initiated WGTA between July 2014 and December 2017 |
| Usual care controls | – | Genetic: Usual careMatched controls who received usual care and were diagnosed with metastatic cancer prior to December 2017 |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BC Cancer administrative data will be used to identify adult patients diagnosed with cancer and residing in BC during the study period who either: 1. Had advanced, incurable cancer and enrolled in the BC Cancer POG Program OR 2. Whose prior staging information, healthcare utilization and/or treatment history indicated they had advanced cancers and who were matched on a baseline covariates at their date of metastatic disease diagnosis.
Key inclusion criteria (9 listed)
- BC residency
- Metastatic disease considered incurable by their treating oncologist
- Life expectancy > 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Consented to POG and undergone initial biopsy between July 2014 and December 2017
Key exclusion criteria (3 listed)
- BC Medical Services Plan personal health number missing or invalid
- Cancer case diagnosed at death
- Age at diagnosis ≤18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initiation of POG-related WGTAPOG-related WGTA generally involves collecting biopsy samples, applying whole-genome and transcriptome sequencing, and using bioinformatics analysis to interpret sequence data and inform clinical decision-making. | Genetic | POG patients |
| Usual careUsual care, not involving the initiation of POG-related WGTA | Genetic | Usual care controls |
Primary outcome
Overall Survival
Time frame: From 1 year up to 4.5 years, adjusted for censoring
Identified from BC Cancer Registry data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Background: PubMed 27148575Laskin J, Jones S, Aparicio S, Chia S, Ch'ng C, Deyell R, Eirew P, Fok A, Gelmon K, Ho C, Huntsman D, Jones M, Kasaian K, Karsan A, Leelakumari S, Li Y, Lim H, Ma Y, Mar C, Martin M, Moore R, Mungall A, Mungall K, Pleasance E, Rassekh SR, Renouf D, Shen Y, Schein J, Schrader K, Sun S, Tinker A, Zhao E, Yip S, Marra MA. Lessons learned from the application of whole-genome analysis to the treatment of patients with advanced cancers. Cold Spring Harb Mol Case Stud. 2015 Oct;1(1):a000570. doi: 10.1101/mcs.a000570.
- BackgroundDiamond A, Sekhon JS. Genetic matching for estimating causal effects: A general multivariate matching method for achieving balance in observational studies. Review of Economics and Statistics. 95(3):932-945, 2013.
- Protocol for BC Cancer Personalized OncoGenomics ProgramLink provided by the sponsor.
- Website for BC Cancer Personalized OncoGenomics ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No. The patient-level administrative data used in this retrospective study are confidential and will not be made available in a public repository, in accordance with institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Advanced Cancer, run by British Columbia Cancer Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From 1 year up to 4.5 years, adjusted for censoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141397, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.