Accelerating Lung Cancer Diagnosis Through Liquid Biopsy (ACCELERATE)

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 Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: Liquid Biopsy

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the UHN Lung Cancer Rapid Assessment & Management Program (Lung RAMP) with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer.

Description

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Advanced NSCLC; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment	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.	Up to 18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment - non-smoker subgroup	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.	Up to 18 Months
Turnaround time	Calculate the time (in days) from the date of request for testing to the report date for both liquid biopsy and tissue biopsy.	Up to 18 Months
Concordance between liquid and tissue	Count the number of actionable targets identified by liquid biopsy and by tissue biopsy, by patient, that were in agreement.	Up to 18 Months
Costs of upfront use of liquid biopsy vs standard tissue profiling	A cost-effectiveness model will be developed comparing the initial use of liquid biopsy versus the current standard of tissue biopsy and profiling.	Up to 24 Months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: The Princess Margaret Cancer Foundation; Lung Health Foundation

Publications and helpful links

General Publications

• Garcia-Pardo M, Czarnecka-Kujawa K, Law JH, Salvarrey AM, Fernandes R, Fan ZJ, Waddell TK, Yasufuku K, Liu G, Donahoe LL, Pierre A, Le LW, Gunasegaran T, Ghumman N, Shepherd FA, Bradbury PA, Sacher AG, Schmid S, Corke L, Feng J, Stockley T, Pal P, Rogalla P, Pipinikas C, Howarth K, Ambasager B, Mezquita L, Tsao MS, Leighl NB. Association of Circulating Tumor DNA Testing Before Tissue Diagnosis With Time to Treatment Among Patients With Suspected Advanced Lung Cancer: The ACCELERATE Nonrandomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325332. doi: 10.1001/jamanetworkopen.2023.25332.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): July 25, 2023
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Biopsy; Cytodiagnosis; Liquid Biopsy
• Other Study ID Numbers: 20-5915

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No