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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564079
• Other study ID #: Exactis-01
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2023
• Source: Exactis Innovation
• Contact: Irine Islam
• Phone: 514-282-4523
• Email: sislam[@]exactis.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• NSCLC

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire Dr-Georges-L.-Dumont	Moncton	New Brunswick
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Centre hospitalier universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Exactis Innovation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory - Analytical validity of Oncomine Precision Assay	Number of genomic aberrations concordant and discordant between tissue and blood using the Oncomine Precision Assay	2 years
Other	Exploratory- Sensitivity and specificity of mutation detection analysis of extracellular vesicles (EV) total nucleic acids	Compare the sensitivity and specificity of mutation detection in extracellular vesicles (EV) total nucleic acids and circulating tumor total nucleic acids	2 years
Other	Exploratory- Explore the response patterns to treatment based on EV RNAs	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.	2 years
Primary	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	1 year
Secondary	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		2 years
Secondary	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		2 years

External Links

•   exactis.ca
•   PMT registry