Clinical trial · Observational
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
NCT04564079CI-TRIAL-00085461completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare the number of genomic aberrations detected by the Oncomine Precision Assay vs Standard of Care
- timeFrame
- 1 year
- 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
Secondary outcomes (2)
- 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
- timeFrame
- 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
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.