Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

Non-small Cell Lung Cancer Clinical Trial

— ACCELERATE  

Official title:

Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04863924
• Other study ID #: 20-5915
• Status: Active, not recruiting
• Start date: January 14, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Diagnostic Test:
• Liquid Biopsy
All patients will have a liquid biopsy with ctDNA molecular profiling

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Lung Health Foundation, The Princess Margaret Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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