Accelerating Lung Cancer Diagnosis Through Liquid Biopsy (ACCELERATE)
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|ClinicalTrials.gov Identifier: NCT04863924|
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment|
|Non-small Cell Lung Cancer||Diagnostic Test: Liquid Biopsy|
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|Official Title:||Accelerating Lung Cancer Diagnosis Through Liquid Biopsy|
|Actual Study Start Date :||January 14, 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||December 2023|
Patients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer
Diagnostic Test: Liquid Biopsy
All patients will have a liquid biopsy with ctDNA molecular profiling
- 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.
- Time to treatment - non-smoker subgroup [ Time Frame: 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 [ Time Frame: 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.
- Concordance between liquid and tissue [ Time Frame: Up to 18 Months ]Count the number of actionable targets identified by liquid biopsy and by tissue biopsy, by patient, that were in agreement.
- Costs of upfront use of liquid biopsy vs standard tissue profiling [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863924
|Contact: Jennifer Law (Research Manager)||416-946-2259||Jennifer.Law@uhn.ca|
|Princess Margaret Cancer Centre||Recruiting|
|Contact: Natasha Leighl, MD|