An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network
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 Within the Exactis Network
1 other identifier
observational
100
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2023
CompletedFebruary 4, 2025
February 1, 2025
2.1 years
August 28, 2020
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the number of genomic aberrations detected by the Oncomine Precision Assay vs Standard of Care
Proportion of patients for whom an actionable 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
1 year
Secondary Outcomes (2)
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
2 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
2 years
Other Outcomes (3)
Exploratory - Analytical validity of Oncomine Precision Assay
2 years
Exploratory- Sensitivity and specificity of mutation detection analysis of extracellular vesicles (EV) total nucleic acids
2 years
Exploratory- Explore the response patterns to treatment based on EV RNAs
2 years
Eligibility Criteria
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).
You may qualify if:
- 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
- No prior treatment for advanced or metastatic NSCLC, except for palliative radiation therapy to non-lung or non-thorax metastases. Patients who received palliative radiation therapy to metastases located within or approximately to the lung or thorax must be evaluated for eligibility.
- Willing and able to provide adequate blood sample prior to starting treatment.
- Willing to provide primary or metastatic tissue, if available.
- Signed and dated Research Ethics Board (REB)-approved informed consent form for Exactis-01 or PMT.
- Not pregnant or breastfeeding
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Centre hospitalier universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, E1C 2Z3, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5H3, Canada
Related Links
Biospecimen
Blood samples and/or tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Agulnik, MD
Principal Investigator
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 25, 2020
Study Start
June 1, 2021
Primary Completion
July 18, 2023
Study Completion
November 21, 2023
Last Updated
February 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
As in the PMT registry, data and samples will be collected, coded and stored in secure and protected installations. Information and samples provided to researchers will be double-coded so that they cannot be traced back to you. Exactis takes great care to protect participants' data and samples, to minimize security risks and the possibility of a confidentiality breach.