Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Study Overview
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Brief Summary
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Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.

Detailed Description
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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.

Official Title
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Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Conditions
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Breast Neoplasms, Lymphoma

Intervention / Treatment
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* Diagnostic Test: Contrast Microhalography (CEM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Botswana citizen Age 18 years or older Able and willing to provide informed consent Undergoing diagnostic procedure for palpable abnormality (biopsy, node/mass resection, or fine-needle aspirate) for diagnosis of possible lymphoid malignancy or breast cancer Exclusion Criteria: Involuntary incarceration (prison, jail, etc.) Procedures involving internal organs or locations expected to have elevated risk of complication Increased risk for severe bleeding as defined as known hemophilia or other bleeding disorder, use of anticoagulants in past week (not including aspirin or other NSAIDS), advanced liver disease, or other condition determined by clinician to significantly increase bleeding risk of procedure Known pregnancy Critical illness as defined by current intensive care admission, hypotension (systolic BP<100mmHg), hypoxemia (O2 saturation <94% on room air), or other condition determined by clinician to significantly decrease physiologic tolerance of procedure Other condition felt by the clinician performing procedure to significantly increase risk of procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard diagnosis and CEM platform<br>Participants will receive standard diagnostic approach and assessment by CEM platform | Diagnostic Test: Contrast Microhalography (CEM)<br>* Fine needle aspirates evaluated by CEM device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 1, at time of diagnosis | 
| Time to diagnosis | Time from diagnostic procedure to knowledge of test result by the treating clinician | 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 | Day 1, At completion of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 1, at time of diagnosis |