NCT05057234

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable cancer

Timeline
13mo left

Started Jun 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2021Jun 2027

Study Start

First participant enrolled

June 18, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

July 2, 2021

Last Update Submit

September 22, 2025

Conditions

Cancer

Keywords

next generation sequencing panelcost consequenceliquid biopsyctDNA

Outcome Measures

Primary Outcomes (2)

  • 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

    12 months

  • 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.

    24 months

Secondary Outcomes (6)

  • Simultaneous: 18 and 24-month health resource utilization

    24 months

  • Simultaneous: Clinical utility

    24 months

  • Simultaneous: Diagnostic pathway impact

    24 months

  • Simultaneous: Quality of Life

    24 months

  • Sequential: Clinical utility

    24 months

  • +1 more secondary outcomes

Study Arms (3)

Simultaneous - FoundationOne liquid CDx

EXPERIMENTAL

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

Diagnostic Test: FoundationOne liquid CDxBehavioral: Quality of life questionnaires

Simultaneous - no additional testing

EXPERIMENTAL

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

Behavioral: Quality of life questionnaires

Sequential - FoundationOne liquid CDx

EXPERIMENTAL

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

Diagnostic Test: FoundationOne liquid CDxBehavioral: Quality of life questionnaires

Interventions

FoundationOne liquid CDxDIAGNOSTIC_TEST

FoundationOne liquid CDx testing

Sequential - FoundationOne liquid CDxSimultaneous - FoundationOne liquid CDx
Quality of life questionnairesBEHAVIORAL

Quality of life questionnaire - EQ5D

Sequential - FoundationOne liquid CDxSimultaneous - FoundationOne liquid CDxSimultaneous - no additional testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z4E6, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Cheryl Ho, MD

    BC Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

September 27, 2021

Study Start

June 18, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

CA(1)