PRecision Oncology Evidence Development in Cancer Treatment - Liquid

NCT ID: NCT05057234

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2027-06-01

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Simultaneous - FoundationOne liquid CDx

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

Group Type: EXPERIMENTAL

FoundationOne liquid CDx

Intervention Type: DIAGNOSTIC_TEST

FoundationOne liquid CDx testing

Quality of life questionnaires

Intervention Type: BEHAVIORAL

Quality of life questionnaire - EQ5D

Simultaneous - no additional testing

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

Group Type: EXPERIMENTAL

Quality of life questionnaires

Intervention Type: BEHAVIORAL

Quality of life questionnaire - EQ5D

Sequential - FoundationOne liquid CDx

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

Group Type: EXPERIMENTAL

FoundationOne liquid CDx

Intervention Type: DIAGNOSTIC_TEST

FoundationOne liquid CDx testing

Quality of life questionnaires

Intervention Type: BEHAVIORAL

Quality of life questionnaire - EQ5D

Interventions

FoundationOne liquid CDx

FoundationOne liquid CDx testing

Intervention Type: DIAGNOSTIC_TEST

Quality of life questionnaires

Quality of life questionnaire - EQ5D

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Ho, MD

Role: PRINCIPAL_INVESTIGATOR

BC Cancer

Locations

BC Cancer

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

PREDiCTl

Identifier Type: -

Identifier Source: org_study_id