Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Diagnostic Test: Liquid Biopsy

• Registration Number: NCT04863924
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This study will assess the utility of liquid biopsy to accelerate the time to treatment for patients with newly diagnosed advanced non-small cell lung cancer, compared to the conventional diagnostic pathway of molecular testing of tumour tissue after imaging and biopsy.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-14
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Lung RAMP Multidisciplinary Cancer Conference or study team confirms radiologic (clinical) evidence of advanced, unresectable lung cancer;
2. Measurable disease (presumed malignant) by RECIST 1.1;
3. Age ≥18 years;
4. Ability to provide written informed consent;
5. Diagnostic biopsy and molecular profiling ordered or planned. Patients remain eligible even if biopsy or tumour testing later fails or is deemed not feasible.

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Exclusion Criteria

1. Pregnancy;
2. Concurrent active malignancy except for localized non-melanomatous skin cancer or non-invasive cervical cancer. Any previous cancer (excluding NSCLC) must have been treated more than 2 years prior to study entry with no current evidence of active disease.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced NSCLC	Liquid Biopsy	Patients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer

Primary Outcome Measures

Name	Time	Method
Time to treatment	Up to 18 Months	The time to treatment decision (TLB) in the study cohort by liquid (TL) and tissue biopsy (TB) is measured from the date of referral to the earliest date of receiving a liquid or tissue biopsy report indicating actionable genomic aberrations, or TLB = min (TL, TB). The time to treatment decision using tissue biopsy alone (TB) will be collected in a chart-review comparison cohort (patients referred in the previous 12 months that meet the eligibility criteria). The time to treatment decision by liquid biopsy (TLB) vs by tissue biopsy alone (TB) will be compared.

Secondary Outcome Measures

Name	Time	Method
Concordance between liquid and tissue	Up to 18 Months	Count the number of actionable targets identified by liquid biopsy and by tissue biopsy, by patient, that were in agreement.
Time to treatment - non-smoker subgroup	Up to 18 Months	Measure the time to treatment, using the same parameters as the primary outcome measure, in a subgroup of patients with advanced non-squamous NSCLC with a smoking history of ≤15 pack years.
Turnaround time	Up to 18 Months	Calculate the time (in days) from the date of request for testing to the report date for both liquid biopsy and tissue biopsy.
Costs of upfront use of liquid biopsy vs standard tissue profiling	Up to 24 Months	A cost-effectiveness model will be developed comparing the initial use of liquid biopsy versus the current standard of tissue biopsy and profiling.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Canada