## Protocol Section
### Identification Module
**NCT ID:** NCT04564079

**Brief Title:** An Observational Study to Evaluate the Clinical Utility of the Oncomine Precision Assay Within the Exactis Network

**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

#### Organization Study ID Info
**ID:** Exactis-01
#### Organization
**Class:** OTHER
**Full Name:** Exactis Innovation
### Status Module
#### Completion Date
**Date:** 2023-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-06-01

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2020-09-25
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-28
**Study First Submit QC Date:** 2020-09-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Exactis Innovation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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

**Detailed 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.

### Conditions Module

**Conditions:**

- NSCLC

**Keywords:**

- Genomic Aberrations

- Exactis Network

- Advanced or Metastatic Non-Small Cell Lung Cancer

- Liquid Biopsy

### Design Module

#### Bio Spec

**Description:** Blood samples and/or tissue

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Other Outcomes

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

**Measure:** Exploratory - Analytical validity of Oncomine Precision Assay

**Time Frame:** 2 years

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

**Measure:** Exploratory- Sensitivity and specificity of mutation detection analysis of extracellular vesicles (EV) total nucleic acids

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Exploratory- Explore the response patterns to treatment based on EV RNAs

**Time Frame:** 2 years

#### Primary Outcomes

**Description:** 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

**Measure:** To compare the number of genomic aberrations detected by the Oncomine Precision Assay vs Standard of Care

**Time Frame:** 1 year

#### Secondary Outcomes

**Measure:** 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

**Time Frame:** 2 years

**Measure:** 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

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 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).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sislam@exactis.ca

**Name:** Irine Islam

**Phone:** 514-282-4523

**Phone Ext:** 212

**Role:** CONTACT

**Contact 2:**

**Email:** ddellarocca@exactis.ca

**Name:** Dina Della Rocca

**Phone:** 514-282-4523

**Phone Ext:** 207

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Moncton

**Contacts:**

***Contact 1:***

- **Email:** Stephanie.Crapoulet@vitalitenb.ca

- **Name:** Stéphanie Crapoulet

- **Phone:** 506-862-4221

- **Role:** CONTACT

***Contact 2:***

- **Name:** Nicholas Finn, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Centre hospitalier universitaire Dr-Georges-L.-Dumont

**State:** New Brunswick

**Status:** RECRUITING

**Zip:** E1C 2Z3

**Location 2:**

**City:** Moncton

**Contacts:**

***Contact 1:***

- **Email:** Ian.Chute@HorizonNB.ca

- **Name:** Ian Chute

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mahmoud Abdelsalam, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** The Moncton Hospital

**State:** New Brunswick

**Status:** RECRUITING

**Zip:** E1C 6Z8

**Location 3:**

**City:** Ottawa

**Contacts:**

***Contact 1:***

- **Email:** natremblay@ohri.ca

- **Name:** Nathalie Tremblay

- **Role:** CONTACT

***Contact 2:***

- **Name:** Arif Awan, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** The Ottawa Hospital

**State:** Ontario

**Status:** RECRUITING

**Zip:** K1H 8L6

**Location 4:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Email:** Roxanne.Fernandes@uhn.ca

- **Name:** Roxanne Fernandes

- **Phone:** 416-946-4501

- **Phone Ext:** 3592

- **Role:** CONTACT

***Contact 2:***

- **Name:** Natasha Leighl, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Princess Margaret Cancer Centre

**State:** Ontario

**Status:** RECRUITING

**Zip:** M5G 2C1

**Location 5:**

**City:** Montreal

**Contacts:**

***Contact 1:***

- **Email:** cmarcangione@jgh.mcgill.ca

- **Name:** Caterina Marcangione

- **Role:** CONTACT

***Contact 2:***

- **Email:** benedicte.foveau@ladydavis.ca

- **Name:** Benedicte Foveau

- **Role:** CONTACT

***Contact 3:***

- **Name:** Jason Agulnik, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Jewish General Hospital

**State:** Quebec

**Status:** RECRUITING

**Zip:** H3T 1E2

**Location 6:**

**City:** Sherbrooke

**Contacts:**

***Contact 1:***

- **Email:** noemie.poirier.ciussse-chus@ssss.gouv.qc.ca

- **Name:** Noemie Poirier

- **Role:** CONTACT

***Contact 2:***

- **Email:** suzanne.maltais.ciussse-chus@ssss.gouv.qc.ca

- **Name:** Suzanne Maltais

- **Role:** CONTACT

***Contact 3:***

- **Name:** Nicole Bouchard, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Centre hospitalier universitaire de Sherbrooke (CHUS)

**State:** Quebec

**Status:** RECRUITING

**Zip:** J1H 5H3

#### Overall Officials

**Official 1:**

**Affiliation:** Principal Investigator

**Name:** Jason Agulnik, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** 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.

**IPD Sharing:** YES

### References Module

#### See Also Links

**Label:** exactis.ca

**URL:** https://www.exactis.ca

**Label:** PMT registry

**URL:** http://clinicaltrials.gov/ct2/show/NCT02355171?term=personalize+me+treatment&draw=2&rank=9

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
