- Determine the accuracy of the CEM platform, compared with standard diagnostic approach, for the diagnosis of non-Hodgkin lymphoma among patients suspected of lymphoid malignancy.
- Determine the accuracy of the CEM platform, compared with standard diagnostic approach, for the diagnosis of invasive breast cancer among patients suspected of the disease.
- Determine whether laboratory personnel of varying experience can accurately perform testing using the CEM platform.
- Assess potential impact of CEM platform on time from diagnostic procedure to knowledge of test result by the treating clinician.
Study Design: Prospective, observational, hybrid implementation and effectiveness study. Project includes a validation study of a novel diagnostic comparing against a gold-standard, assessment of training requirements, and assessment of projected impact on result turn-around time.
- Cancer suspects (objective 1,2, and 4) - Up to 400 lymphoid malignancy suspects and 400 breast cancer suspects.
- Laboratory Science Students (objective 3) - Up to 100 university students enrolled in disciplines involving laboratory practice.
The proposed study will involve male and female adults (age >18) suspected of having a lymphoid malignancy or breast cancer. For the training objective, male and female laboratory science students will be involved.
Study Duration: 3 years