Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network

NCT04564079

NSCLC

COMPLETED

Achieving Value in Cancer Diagnostics: Blood Versus Tissue Molecular Profiling - a Prospective Canadian Study

NCT03576937

Non-small Cell Lung Cancer

COMPLETED

PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers

NCT00136890

Non-small-cell Lung Carcinoma

COMPLETED PHASE3

Novel Detection System for Lung Cancer Curative Effect Monitoring

NCT02666755

Lung Neoplasms

UNKNOWN

Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

NCT00751660

Lung Cancer Tobacco Use Disorder

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Stage IV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stage IV Lung Adenocarcinoma

Oncomine Comprehensive Assay

Intervention Type DIAGNOSTIC_TEST

Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oncomine Comprehensive Assay

Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No