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NCT Number: NCT04863924

Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Liquid Biopsy

Diagnostic Test

All patients will have a liquid biopsy with ctDNA molecular profiling

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Lung Health Foundation
  • The Princess Margaret Cancer Foundation

Registry information

Acronym: ACCELERATE

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Apr 28, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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