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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
Sponsor:
Collaborators:
Lung Health Foundation
Princess Margaret Cancer Foundation
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Diagnostic Test: Liquid Biopsy

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Law (Research Manager) 416-946-2259 Jennifer.Law@uhn.ca

Locations
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Canada
Princess Margaret Cancer Centre Recruiting
Toronto, Canada
Contact: Natasha Leighl, MD         
Sponsors and Collaborators
University Health Network, Toronto
Lung Health Foundation
Princess Margaret Cancer Foundation
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04863924    
Other Study ID Numbers: 20-5915
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases