Non-small Cell Lung CancerACCELERATENCT04863924
Accelerating Lung Cancer Diagnosis Through Liquid Biopsy
An observational study of Non-small Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Liquid Biopsy
- Type of treatment
- Injection or infusion
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Liquid Biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid BiopsyDiagnostic test
All patients will have a liquid biopsy with ctDNA molecular profiling
| Study group | Role | What they receive |
|---|---|---|
| Advanced NSCLC | Patients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer Receives: Diagnostic Test: Liquid Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 Months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start14 Jan 2021
- Primary completion25 Jul 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Lung Health Foundation, The Princess Margaret Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863924
- Sponsor's protocol ID
- 20-5915
- Acronym
- ACCELERATE
- Status last verified
- Dec 2025
- First submitted
- 26 Apr 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37490292
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Lung Cancer Diagnosis Through Liquid Biopsy
- ClinicalTrials.gov ID
- NCT04863924
- Acronym / sponsor ID
- ACCELERATE / 20-5915
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Lung Health Foundation, The Princess Margaret Cancer Foundation
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced NSCLC | – | Diagnostic Test: Liquid BiopsyPatients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid BiopsyAll patients will have a liquid biopsy with ctDNA molecular profiling | Diagnostic test | Advanced NSCLC |
Primary outcome
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.
4 secondary outcomes
Time to treatment - non-smoker subgroup
Time frame: Up to 18 Months
Turnaround time
Time frame: Up to 18 Months
Concordance between liquid and tissue
Time frame: Up to 18 Months
Costs of upfront use of liquid biopsy vs standard tissue profiling
Time frame: Up to 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 37490292Garcia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment (time frame: Up to 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.