Study Objectives

  1. 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.
  2. 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.
  3. Determine whether laboratory personnel of varying experience can accurately perform testing using the CEM platform.
  4. 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.

Study Population

  • 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 

Sponsor: NIH/NCI.