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NGS Panel

Tissue vs Liquid Biopsy for Cancer Diagnosis (PREDiCTl Trial)

N/A

Recruiting

Led By Cheryl Ho, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18

Patients with metastatic malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

PREDiCTl Trial Summary

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

Who is the study for?

This trial is for adults over 18 with metastatic cancer, treated at BC Cancer, who are undergoing or have recently undergone tissue-based molecular characterization. It's not suitable for those unwilling to consider systemic treatments or unavailable for follow-up.Check my eligibility

What is being tested?

The study compares traditional tissue-based next-generation sequencing (NGS) panel testing with a new liquid biopsy method using blood samples to see how well each detects cancer mutations and assesses the cost implications of the new technology in British Columbia.See study design

What are the potential side effects?

There are no direct side effects from participating in this trial as it involves non-invasive procedures like questionnaires and blood tests rather than drug interventions.

PREDiCTl Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Select...

My cancer has spread to other parts of my body.

Select...

My cancer does not have a significant genetic mutation based on a specific test, or the test couldn't be done.

PREDiCTl Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Simultaneous: 12-month health resource utilization

Secondary outcome measures

Sequential: Clinical utility

Sequential: Proportion of patients with insufficient tissue for molecular characterization

Simultaneous: 18 and 24-month health resource utilization

+3 more

PREDiCTl Trial Design

3Treatment groups

Experimental Treatment

Group I: Simultaneous - no additional testingExperimental Treatment1 Intervention

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

Group II: Simultaneous - FoundationOne liquid CDxExperimental Treatment2 Interventions

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

Group III: Sequential - FoundationOne liquid CDxExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality of life questionnaires

2013

N/A

~1450

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

89,011 Total Patients Enrolled

Roche Pharma AGIndustry Sponsor

408 Previous Clinical Trials

394,296 Total Patients Enrolled

Cheryl Ho, MDPrincipal InvestigatorBC Cancer

4 Previous Clinical Trials

171 Total Patients Enrolled

Media Library

FoundationOne liquid CDx (NGS Panel) Clinical Trial Eligibility Overview. Trial Name: NCT05057234 — N/A

Cancer Research Study Groups: Simultaneous - no additional testing, Simultaneous - FoundationOne liquid CDx, Sequential - FoundationOne liquid CDx

Cancer Clinical Trial 2023: FoundationOne liquid CDx Highlights & Side Effects. Trial Name: NCT05057234 — N/A

FoundationOne liquid CDx (NGS Panel) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05057234 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRecision Oncology Evidence Development in Cancer Treatment - Liquid

2021. "PRecision Oncology Evidence Development in Cancer Treatment - Liquid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05057234.