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出境医 / 临床实验 / Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay (LU-NGS-2)

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

Study Description
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

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 134 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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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

Contacts and Locations

Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Princess Margaret Cancer Foundation
Tracking Information
First Submitted Date May 7, 2018
First Posted Date June 15, 2018
Last Update Posted Date April 27, 2021
Actual Study Start Date March 1, 2018
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2018)
  • 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.
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2018)
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay
Official Title Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Cancer Panel
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Eligible patients will be recruited at outpatient thoracic oncology clinics at the Princess Margaret Cancer Centre.
Condition Lung Cancer Stage IV
Intervention Diagnostic Test: Oncomine Comprehensive Assay
Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay
Study Groups/Cohorts Stage IV Lung Adenocarcinoma
Intervention: Diagnostic Test: Oncomine Comprehensive Assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 26, 2021) 		134
Original Estimated Enrollment
 (submitted: June 4, 2018) 		100
Estimated Study Completion Date February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03558165
Other Study ID Numbers 17-5638
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators
  • Princess Margaret Hospital, Canada
  • Princess Margaret Cancer Foundation
Investigators Not Provided
PRS Account University Health Network, Toronto
Verification Date April 2021

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