NSCLCNCT04564079
An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network
An observational study of NSCLC, run by Exactis Innovation at 6 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- How many people
- 100 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Jun 2021to 21 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Centre hospitalier universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, E1C 2Z3
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5H3
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
About this study
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
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
Read the 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.
- Conditions
- NSCLC
- Keywords
- Genomic Aberrations, Exactis Network, Advanced or Metastatic Non-Small Cell Lung Cancer, Liquid Biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Jun 2021
- Primary completion18 Jul 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactis Innovation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Agulnik, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564079
- Sponsor's protocol ID
- Exactis-01
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2020
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04564079
- Acronym / sponsor ID
- Exactis-01
- Conditions
- NSCLC
- Keywords
- Genomic Aberrations, Exactis Network, Advanced or Metastatic Non-Small Cell Lung Cancer, Liquid Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Exactis InnovationUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 25 Sep 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the number of genomic aberrations detected by the Oncomine Precision Assay vs Standard of Care
Time frame: 1 year
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
2 secondary outcomes
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
Time frame: 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
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- exactis.caLink provided by the sponsor.
- PMT registryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Jason Agulnik, MD principal investigator
Principal Investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Exactis Innovation at 6 sites 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the number of genomic aberrations detected by the Oncomine Precision Assay vs Standard of Care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.