Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Irine Islam

Dina Della Rocca

Stéphanie Crapoulet

Nicholas Finn, MD

Ian Chute

Mahmoud Abdelsalam, MD

Nathalie Tremblay

Arif Awan, MD

Roxanne Fernandes

Natasha Leighl, MD

Caterina Marcangione

Benedicte Foveau

Jason Agulnik, MD

Noemie Poirier

Suzanne Maltais

Nicole Bouchard, MD

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

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.

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

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.

Number of genomic aberrations concordant and discordant between tissue and blood using the Oncomine Precision Assay

Compare the sensitivity and specificity of mutation detection in extracellular vesicles (EV) total nucleic acids and circulating tumor total nucleic acids

Small RNA extracted from plasma EV at baseline and at progression will be analyzed using RNA sequencing. Potential association between expression profiles and clinical parameters such as treatment response will be explored and candidate patterns predictive of treatment response will be tested using artificial intelligence algorithms.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network	NCT04564079	NSCLC		18 Years -	Exactis Innovation
An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network	NCT04564079	NSCLC		18 Years -	Exactis Innovation

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