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Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay (LU-NGS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558165
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : July 5, 2019
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
Princess Margaret Cancer Foundation
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.

Condition or disease Intervention/treatment
Lung Cancer Stage IV Diagnostic Test: Oncomine Comprehensive Assay

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stage IV Lung Adenocarcinoma Diagnostic Test: Oncomine Comprehensive Assay
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay




Primary Outcome Measures :
  1. Incremental actionable targets [ Time Frame: 8-12 weeks from Oncomine Comprehensive Assay testing ]
    Calculate the number of incremental actionable targets identified by the Oncomine Comprehensive Assay compared to current standard of care molecular profiling (EGFR, ALK) in patients with stage IV NSCLC.

  2. Number of clinical trial opportunities [ Time Frame: 1 year from Oncomine Comprehensive Assay testing ]
    Compile the number of clinical trial opportunities that patients with stage IV NSCLC would be eligible for based on targets identified by the Oncomine Comprehensive Assay compared to standard of care molecular profiling (EGFR, ALK).


Secondary Outcome Measures :
  1. Test turnaround time [ Time Frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). ]
    Calculate the time to receive Oncomine Comprehensive Assay results compared to the standard of care tissue molecular test turnaround time (EGFR, ALK).

  2. Financial feasibility [ Time Frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). ]
    Perform a cost consequence analysis to evaluate financial feasibility of the Oncomine Comprehensive Assay.

  3. Patient willingness-to-pay [ Time Frame: To be assessed after accruing 50 patients (up to 2.5 years) and after 100 patients (up to 5 years). ]
    Evaluate patient willingness-to-pay for using a next generation sequencing assay, like the Oncomine Comprehensive Assay, using a validated patient survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
  • Stage IV disease
  • Sufficient FFPE tumour tissue for OCCP testing
  • Performance status 0-2
  • Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
  • Prognosis > 6 months
  • Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed

Exclusion Criteria:

● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558165


Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Natasha Leighl, MD    416-946-4645    Natasha.Leighl@uhn.ca   
Principal Investigator: Natasha Leighl, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Princess Margaret Cancer Foundation
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03558165    
Other Study ID Numbers: 17-5638
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases