Accelerating Lung Cancer Diagnosis Through Liquid Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Time to treatment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Lung RAMP Multidisciplinary Cancer Conference or study team confirms radiologic (clinical) evidence of advanced, unresectable lung cancer;
- •Measurable disease (presumed malignant) by RECIST 1.1;
- •Age ≥18 years;
- •Ability to provide written informed consent;
- •Diagnostic biopsy and molecular profiling ordered or planned. Patients remain eligible even if biopsy or tumour testing later fails or is deemed not feasible.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Time to treatment
Time Frame: 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 Outcomes
- Concordance between liquid and tissue(Up to 18 Months)
- Time to treatment - non-smoker subgroup(Up to 18 Months)
- Turnaround time(Up to 18 Months)
- Costs of upfront use of liquid biopsy vs standard tissue profiling(Up to 24 Months)