FoundationOne liquid CDx for Cancer

BC Cancer, Vancouver, Canada
CancerFoundationOne liquid CDx - DiagnosticTest
Eligibility
18+
All Sexes

Study Summary

This trial compares the effectiveness of two methods of cancer diagnosis- through studying tissue, and through studying liquid biopsies (blood).

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 24 months

12 months
Simultaneous: 12-month health resource utilization
24 months
Sequential: Clinical utility
Sequential: Proportion of patients with an actionable sequencing result following uninformative standard care oncopanel results, treated at BC Cancer, outside Vancouver Centre.
Sequential: Proportion of patients with insufficient tissue for molecular characterization
Simultaneous: 18 and 24-month health resource utilization
Simultaneous: Clinical utility
Simultaneous: Diagnostic pathway impact
Simultaneous: Quality of Life

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Simultaneous - no additional testing
1 of 3
Simultaneous - FoundationOne liquid CDx
1 of 3
Sequential - FoundationOne liquid CDx
1 of 3

Experimental Treatment

1500 Total Participants · 3 Treatment Groups

Primary Treatment: FoundationOne liquid CDx · No Placebo Group · N/A

Simultaneous - no additional testing
Behavioral
Experimental Group · 1 Intervention: Quality of life questionnaires · Intervention Types: Behavioral
Simultaneous - FoundationOne liquid CDxExperimental Group · 2 Interventions: Quality of life questionnaires, FoundationOne liquid CDx · Intervention Types: Behavioral, DiagnosticTest
Sequential - FoundationOne liquid CDxExperimental Group · 2 Interventions: Quality of life questionnaires, FoundationOne liquid CDx · Intervention Types: Behavioral, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality of life questionnaires
2013
N/A
~1450

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
166 Previous Clinical Trials
89,046 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
393 Previous Clinical Trials
358,566 Total Patients Enrolled
Cheryl Ho, MDPrincipal InvestigatorBC Cancer
3 Previous Clinical Trials
71 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have cancer that has spread to other parts of your body.
I'm sorry, but the criterion you provided is incomplete or unclear. Please provide more context or information so I can accurately summarize it for you.

Frequently Asked Questions

What is the scope of this clinical research regarding patient participants?

"Affirmative. Records from clinicaltrials.gov demonstrate that this research project, which was initially uploaded on June 18th 2021, is actively enrolling participants. The trial requires 1500 patients to be recruited across 1 location." - Anonymous Online Contributor

Unverified Answer

Is the enrollment window still open for this investigation?

"Clinicaltrials.gov affirms that this research is actively enrolling patients, with the trial posted on June 18th 2021 and its content most recently updated as of August 4th 2022." - Anonymous Online Contributor

Unverified Answer

What are the intended outcomes of this research?

"This trial, which will be measured over a 12 months period of time, is aiming to quantify the number of patients who have an actionable sequencing result upon receiving uninformative standard care oncopanel results. The secondary objectives include evaluating clinical utility through concordance/discordance findings and treatments, as well as gauging the impact FoundationOne liquid CDx has on patient diagnostic pathways by measuring how many repeat biopsies are needed for molecular characterization purposes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.