Breast Neoplasms, Lymphoma
Conditions
Brief summary
Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTContrast Microhalography (CEM)
Fine needle aspirates evaluated by CEM device
Sponsors
National Cancer Institute (NCI)
Botswana Harvard AIDS Institute Partnership
Massachusetts General Hospital
Brigham and Women's Hospital
Harvard School of Public Health (HSPH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking, open label.
Intervention model description
Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy for diagnosis of non-Hodgkin lymphoma | Day 1, at time of diagnosis | Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach. |
| Accuracy for diagnosis of invasive breast cancer | Day 1, at time of diagnosis | Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach. |
| Time to diagnosis | Day 1, at time of diagnosis | Time from diagnostic procedure to knowledge of test result by the treating clinician |
| Proficiency in testing using CEM platform | Day 1, At completion of training | Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma | Day 1, at time of diagnosis | Accuracy (proportion of true positive and true negative out of total number non-Hodgkin lymphoma) of CEM in comparison with standard diagnostic approach. |
| Accuracy for molecular subtype diagnosis of invasive breast cancer | Day 1, at time of diagnosis | 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. |
Countries
Botswana
Outcome results
None listed