Clinical trial NCT05057234: PRecision Oncology Evidence Development in Cancer Treatment - Liquid
Official title: PRecision Oncology Evidence Development in Cancer Treatment - Liquid AKA the Real World Clinical Utility of CtDNA Analysis for Decision Making and Access to Precision Therapy for Advanced Cancer Patients in BC: the RAPTor Sub-study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: next generation sequencing panel
cost consequence
liquid biopsy
ctDNA
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2021-09-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The current standard of care for molecular characterization of tumors is tissue based next generation sequencing (NGS) panel. Liquid biopsies (ie blood) are of increasing interest and have been implemented as a diagnostic tool in some countries. This study compares tissue based and liquid based testing to evaluate the detection rate and cost consequence of using this new tool in BC.

Detailed description: Part A - Simultaneous - Patients will be randomized 1:1 to FoundationOne liquid CDx or no additional testing simultaneously at initiation of request for standard based tissue based next generation sequencing (NGS) panel testing. The objective of Part A is to evaluate the cost-consequence of the liquid ctDNA biopsy technology, FoundationOne liquid CDx, for first line molecular characterization of advanced colorectal cancer, melanoma, non small cell lung cancer (NSCLC), ovarian cancer, prostate cancer and triple negative breast cancer with simultaneous molecular characterization by tissue based NGS panel

Part B - Sequential - Patients will undergo standard tissue based NGS panel testing and if there are no somatic tier 1 variant of strong clinical significance identified the patients will then be eligible for FoundationOne liquid CDx. The objective of Part B is to determine the benefit of a sequential approach with molecular characterization by tissue based NGS panel testing followed by liquid based FoundationOne liquid CDx for patients who do not have an actionable tissue based oncogenic driver, across British Columbia.

The development and access to next generation sequencing (NGS) technologies on tumour tissue and blood allows the ability to profile the genomic landscape of the tumour within reasonable turn-around times and costs. The promise of precision oncology is the ability to 'match the right drug to the right patient at the right time'. Despite considerable excitement at the prospect of genome-informed therapy to improve oncologic outcomes, there has been little empirical assessment of its benefit from an overall population perspective and its true impact on cancer care delivery in 'real-world' scenarios.

While the enthusiasm for liquid biopsies has increased, the understanding of the cost implications lags behind. We propose to assess the true clinical impact on both individual patients and on a population-based cancer system of precision oncology via ctDNA analyses in metastatic solid tumors in a real-world scenario.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Patients with metastatic malignancy
* Patients undergoing tissue based molecular characterization by tissue based NGS panel

Part A - Simultaneous

* Tissue based NGS panel requested or reported within 4 weeks of enrolment
* Patients receiving treatment at BC Cancer

Part B - Sequential

* Tissue based NGS oncopanel does NOT identify a somatic tier 1 variant of strong clinical significance OR fails/not feasible due to insufficient tissue
* BC Cancer - Provincial (not including Vancouver Centre)

Exclusion Criteria:

* Patients not available for follow up
* Patients who are not willing to consider systemic treatment options

Primary outcomes:
measure: Simultaneous: 12-month health resource utilization
timeFrame: 12 months
measure: Sequential: Proportion of patients with an actionable sequencing result following uninformative standard care oncopanel results, treated at BC Cancer, outside Vancouver Centre.
timeFrame: 24 months
Secondary outcomes:
measure: Simultaneous: 18 and 24-month health resource utilization
timeFrame: 24 months
measure: Simultaneous: Clinical utility
timeFrame: 24 months
measure: Simultaneous: Diagnostic pathway impact
timeFrame: 24 months
measure: Simultaneous: Quality of Life
timeFrame: 24 months
measure: Sequential: Clinical utility
timeFrame: 24 months
measure: Sequential: Proportion of patients with insufficient tissue for molecular characterization
timeFrame: 24 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: BC Cancer
name: Cheryl Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: