NCT04141397

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

4.5 years

First QC Date

October 23, 2019

Last Update Submit

January 25, 2021

Conditions

Metastatic CancerAdvanced CancerCancers That Cannot be Treated With Curative Intent

Keywords

precision medicinegenomic sequencingadministrative dataquasi-experimental methodsmatchingclinical effectiveness

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Identified from BC Cancer Registry data

    From 1 year up to 4.5 years, adjusted for censoring

Study Arms (2)

POG patients

Patients enrolled in POG who initiated WGTA between July 2014 and December 2017

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

Genetic: Usual care

Interventions

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.

POG patients
Usual careGENETIC

Usual care, not involving the initiation of POG-related WGTA

Usual care controls

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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
  • BC residents during study period
  • Received care at BC Cancer during study period
  • Alive July 1st 2014

You may not qualify if:

  • BC Medical Services Plan personal health number missing or invalid
  • Cancer case diagnosed at death
  • Age at diagnosis ≤18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27148575BACKGROUND

  • Diamond 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 28, 2019

Study Start

July 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

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.