An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network
Study Details
Study Description
Brief Summary
A Multi-centre Observational Study to Evaluate the Clinical Utility of Returning Genomic Aberration results Using the Oncomine Precision Assay in Advanced or Metastatic Non-Small Cell Lung Cancer Patients within the Exactis Network
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This prospective multi-center observational study will evaluate the clinical utility of returning genomic aberration results in blood and/or tissue using the Oncomine Precision Assay in non-small cell lung cancer (NSCLC) patients. Up to 200 patients with stage IIIb/IV NSCLC will consent to have their blood and tissue profiled on the Oncomine Precision Assay. A baseline plasma sample will be collected for all patients, of which up to 100 patients will have a tissue sample collected from pathology archives or planned biopsy or surgery.
Study Design
Outcome Measures
Primary Outcome Measures
- Demonstrate the non-inferiority of the Oncomine Precision Assay vs Standard of Care [1 year]
Proportion of patients for whom a genomic aberration is detected in at least one of the eight genes (ROS1, ERBB2, MET, BRAF, KRAS, RET, ALK, EGFR) using the Oncomine Precision Assay vs. study site's standard of care
Secondary Outcome Measures
- Clinical utility of returning genomic aberration results by quantifying the number of patients who received targeted therapy based on results returned from the Oncomine Precision Assay genomic aberration results in blood and/or tissue [3 years]
- Clinical utility of returning genomic aberration results by quantifying the number of patients enrolled on a clinical trial based on results returned from the Oncomine Precision Assay in blood and/or tissue [3 years]
- Clinical utility of returning genomic aberration results by measuring the turnaround time (in days) from the date of request for SOC genetic testing in tissue versus date of blood collection for the Oncomine Precision Assay to the report date [3 years]
Other Outcome Measures
- Exploratory - Analytical validity of Oncomine Precision Assay [3 years]
Number of genomic aberrations concordant and discordant between tissue and blood using the Oncomine Precision Assay
- Exploratory- Assessment of tumor evolution using Oncomine Precision Oncology assay on sequential ctDNA samples [3 years]
Mutation, copy number variation and fusion variant types across 50 key genes will be assessed using the Oncomine Precision Assay in blood samples collected at progression from patients that received targeted therapy and compared to the baseline matched specimen.
- Exploratory- Sensitivity and specificity of mutation detection analysis of extracellular vesicles (EV) total nucleic acids [3 years]
Compare the sensitivity and specificity of mutation detection in extracellular vesicles (EV) total nucleic acids and circulating tumor total nucleic acids
- Exploratory- Explore the response patterns to treatment based on EV RNAs [3 years]
Small RNA extracted from plasma EV at baseline and at progression will be analyzed using RNA sequencing. Potential association between expression profiles and clinical parameters such as treatment response will be explored and candidate patterns predictive of treatment response will be tested using artificial intelligence algorithms.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with NSCLC, which is (i) advanced or metastatic (stage IIIb/IV), (ii) non- squamous histology NSCLC as confirmed by local histopathology (mixed squamous and adenocarcinoma is allowed), and has (iii) radiographically measurable disease with at least one bidimensionally measurable lesion of > 1 cm by CT scan
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No prior treatment for advanced or metastatic NSCLC
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Willing and able to provide adequate blood sample prior to starting treatment.
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Willing to provide primary or metastatic tissue, if available.
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Signed and dated Research Ethics Board (REB)-approved informed consent form for Exactis-01 or PMT.
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Not pregnant or breastfeeding
Exclusion Criteria:
• Patients who have a history of another active cancer within the past 2 years from date of consent except cervical cancer in situ, basal cell carcinoma of the skin or another in situ carcinoma that is considered cured by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre hospitalier universitaire Dr-Georges-L.-Dumont | Moncton | New Brunswick | Canada | E1C 2Z3 |
| 2 | The Moncton Hospital | Moncton | New Brunswick | Canada | E1C 6Z8 |
| 3 | QE II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V8 |
| 4 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
| 5 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2C1 |
| 6 | Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 7 | Centre hospitalier universitaire de Sherbrooke (CHUS) | Sherbrooke | Quebec | Canada | J1H 5H3 |
Sponsors and Collaborators
- Exactis Innovation
Investigators
- Principal Investigator: Jason Agulnik, MD, Principal Investigator
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Exactis-01