Clinical trial NCT04564079: An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: Genomic Aberrations
Exactis Network
Advanced or Metastatic Non-Small Cell Lung Cancer
Liquid Biopsy
Lead sponsor: Exactis Innovation
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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

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 100 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 50 patients will have a tissue sample collected from pathology archives or planned biopsy or surgery.

Eligibility criteria: Inclusion 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), 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

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.

Primary outcomes:
measure: To compare the number of genomic aberrations detected by the Oncomine Precision Assay vs Standard of Care
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
Other outcomes:
measure: Exploratory - Analytical validity of Oncomine Precision Assay
timeFrame: 2 years
measure: Exploratory- Sensitivity and specificity of mutation detection analysis of extracellular vesicles (EV) total nucleic acids
timeFrame: 2 years
measure: Exploratory- Explore the response patterns to treatment based on EV RNAs
timeFrame: 2 years
Locations:
city: Moncton
country: Canada
facility: Centre hospitalier universitaire Dr-Georges-L.-Dumont
state: New Brunswick
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke (CHUS)
state: Quebec
Study officials:
affiliation: Principal Investigator
name: Jason Agulnik, MD
role: PRINCIPAL_INVESTIGATOR
References: