Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

NCT04863924 | Active Not Recruiting

• 1 other identifier: 20-5915
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to treatment - non-smoker subgroup

  Up to 18 Months

• Turnaround time

  Up to 18 Months

• Concordance between liquid and tissue

  Up to 18 Months

• Costs of upfront use of liquid biopsy vs standard tissue profiling

  Up to 24 Months

Study Arms (1)

Advanced NSCLC

Patients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer

Diagnostic Test: Liquid Biopsy

Interventions

Liquid Biopsy DIAGNOSTIC_TEST

All patients will have a liquid biopsy with ctDNA molecular profiling

Advanced NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy;
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Lung Health Foundation: collaborator
• The Princess Margaret Cancer Foundation: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Canada

Location

Related Publications (1)

• 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.

  PMID: 37490292 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: January 14, 2021
• Primary Completion: July 25, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CA (1)