Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast cancer will undergo standard diagnostic procedure. Concurrently these patients will have additional FNA fluid tested using the portable novel nanosensor-based device (CEM). Diagnosis made from standard anatomic pathology, flow cytometry, and/or cytology will be compared with the diagnosis made using the CEM platform. Assessment of the feasibility and acceptability of the CEM platform will be performed. Assessment of training requirements for CEM platform will be completed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
270
Fine needle aspirates evaluated by CEM device
Botswana Harvard AIDS Institute
Gaborone, Botswana
Accuracy for diagnosis of non-Hodgkin lymphoma
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Time frame: Day 1, at time of diagnosis
Accuracy for diagnosis of invasive breast cancer
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Time frame: Day 1, at time of diagnosis
Time to diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Time frame: Day 1, at time of diagnosis
Proficiency in testing using CEM platform
Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform
Time frame: Day 1, At completion of training
Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma
Accuracy (proportion of true positive and true negative out of total number non-Hodgkin lymphoma) of CEM in comparison with standard diagnostic approach.
Time frame: Day 1, at time of diagnosis
Accuracy for molecular subtype diagnosis of invasive breast cancer
Accuracy (proportion of true positive and true negative out of total number of invasive breast cancers), compared with standard diagnostic approach, for the molecular subtype diagnosis of invasive breast cancer into estrogen-receptor positive, triple-negative, and other estrogen-receptor negative categories.
Time frame: Day 1, at time of diagnosis
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