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| Name | Class |
|---|---|
| Lung Health Foundation | UNKNOWN |
| The Princess Margaret Cancer Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced NSCLC | Patients with radiologic evidence of advanced (unresectable stage III or IV) non-small cell lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Biopsy | Diagnostic Test | All patients will have a liquid biopsy with ctDNA molecular profiling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Turnaround time |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37490292 | Derived | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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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 |
| 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 |
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |