PRecision Oncology Evidence Development in Cancer Treatment - Liquid (PREDiCTl)

British Columbia Cancer Agency

Status: Enrolling

Conditions: Cancer

Treatments: Diagnostic Test: FoundationOne liquid CDx; Behavioral: Quality of life questionnaires

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05057234

PREDiCTl

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 3 patient groups

Simultaneous - FoundationOne liquid CDx

Experimental group

Description:

Patients undergoing FoundationOne liquid CDx while tissued-based NGS panel is in progress or reported within 4 weeks of enrollment

Treatment:

Behavioral: Quality of life questionnaires

Diagnostic Test: FoundationOne liquid CDx

Simultaneous - no additional testing

Experimental group

Description:

Patients undergoing no additional testing while tissue-based NGS panel is in progress or reported within 4 weeks of enrolment

Treatment:

Behavioral: Quality of life questionnaires

Sequential - FoundationOne liquid CDx

Experimental group

Description:

Patients undergoing FoundationOne liquid CDx if standard tissue based NGS oncopanel testing identifies no somatic tier 1 variant of strong clinical significance

Treatment:

Behavioral: Quality of life questionnaires

Diagnostic Test: FoundationOne liquid CDx