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NCT Number: NCT05057234

PRecision Oncology Evidence Development in Cancer Treatment - Liquid

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Cancer

Vancouver, British Columbia, V5Z4E6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FoundationOne liquid CDx

Diagnostic Test

FoundationOne liquid CDx testing

Quality of life questionnaires

Behavioral

Quality of life questionnaire - EQ5D

Primary outcomes

  1. Simultaneous: 12-month health resource utilization

    Time frame: 12 months

    To compare health resource utilization of tissue based NGS panel alone, versus NGS panel and FoundationOne liquid CDx measured in Canadian dollars

  2. Sequential: Proportion of patients with an actionable sequencing result following uninformative standard care oncopanel results, treated at BC Cancer, outside Vancouver Centre.

    Time frame: 24 months

    To evaluate the ability of FoundationOne liquid CDx to detect actionable mutations that were not identified on the tissue based NGS oncopanel.

Secondary outcomes

  1. Simultaneous: 18 and 24-month health resource utilization

    Time frame: 24 months

    To evaluate the health resource utilization of tissue based NGS panel alone, versus panel and FoundationOne liquid CDx measured in Canadian dollars

  2. Simultaneous: Clinical utility

    Time frame: 24 months

    To evaluate the clinical utility of tissue based NGS oncopanel +/- FoundationOne liquid CDx as measured by concordance/discordance of findings and subsequent treatment

  3. Simultaneous: Diagnostic pathway impact

    Time frame: 24 months

    To assess the impact of FoundationOne liquid CDx on the diagnostic patient pathway by comparing the number of patients who require repeat biopsies for molecular characterization.

  4. Simultaneous: Quality of Life

    Time frame: 24 months

    To compare the quality of life impact of FoundationOne liquid CDx using the validated instrument, EuroQol 5 Dimension (EQ5D) (Scale of 0-100 where 0 is worst health and 100 is best health)

  5. Sequential: Clinical utility

    Time frame: 24 months

    To evaluate the clinical utility of tissue based NGS oncopanel followed by FoundationOne liquid CDx as measured by concordance/discordance of findings and subsequent treatment

  6. Sequential: Proportion of patients with insufficient tissue for molecular characterization

    Time frame: 24 months

    To determine the proportion of tissue based NGS oncopanel completed for which results are not available due to insufficient tissue. To be calculated by assessing number of patients with insufficient tissue for molecular characterization over the number of patients who have molecular characterization performed

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study 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

Acronym: PREDiCTl

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2021
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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