AzTrials
AzTrials

CancerPREDiCTlNCT05057234

PRecision Oncology Evidence Development in Cancer Treatment - Liquid

A study testing FoundationOne liquid CDx and Quality of life questionnaires in people with Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
FoundationOne liquid CDx and Quality of life questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteCanada
Study dates
18 Jun 2021to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Cancer

    Vancouver, British Columbia, V5Z4E6

Other trials in Canada

About this study

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

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.

Read the 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
Being tested
FoundationOne liquid CDx, Quality of life questionnaires
Keywords
next generation sequencing panel, cost consequence, liquid biopsy, ctDNA
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FoundationOne liquid CDxDiagnostic test

    FoundationOne liquid CDx testing

  • Quality of life questionnairesBehavioural

    Quality of life questionnaire - EQ5D

Study groups in NCT05057234
Study groupRoleWhat they receive
Simultaneous - FoundationOne liquid CDxExperimentalPatients undergoing FoundationOne liquid CDx while tissued-based NGS panel is in progress or reported within 4 weeks of enrollment
Receives: Diagnostic Test: FoundationOne liquid CDx; Behavioral: Quality of life questionnaires
Simultaneous - no additional testingExperimentalPatients undergoing no additional testing while tissue-based NGS panel is in progress or reported within 4 weeks of enrolment
Receives: Behavioral: Quality of life questionnaires
Sequential - FoundationOne liquid CDxExperimentalPatients undergoing FoundationOne liquid CDx if standard tissue based NGS oncopanel testing identifies no somatic tier 1 variant of strong clinical significance
Receives: Diagnostic Test: FoundationOne liquid CDx; Behavioral: Quality of life questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Simultaneous: 12-month health resource utilization

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

    Measured: 12 months

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

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

    Measured: 24 months

Secondary outcomes (6)

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

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

    Measured: 24 months

  2. Simultaneous: Clinical utility

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

    Measured: 24 months

  3. Simultaneous: Diagnostic pathway impact

    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.

    Measured: 24 months

  4. Simultaneous: Quality of Life

    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)

    Measured: 24 months

  5. Sequential: Clinical utility

    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

    Measured: 24 months

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

    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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start18 Jun 2021
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057234
Sponsor's protocol ID
PREDiCTl
Acronym
PREDiCTl
Status last verified
Oct 2026
First submitted
2 Jul 2021
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing FoundationOne liquid CDx and Quality of life questionnaires in people with Cancer, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Simultaneous: 12-month health resource utilization (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05057234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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