Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Harvard School of Public Health (HSPH)
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Time to diagnosis
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Scott Dryden-Peterson
Research Associate
Harvard School of Public Health (HSPH)
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time to diagnosis
Time Frame: Day 1, at time of diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Accuracy for diagnosis of invasive breast cancer
Time Frame: 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.
Proficiency in testing using CEM platform
Time Frame: Day 1, At completion of training
Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform
Accuracy for diagnosis of non-Hodgkin lymphoma
Time Frame: 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.
Secondary Outcomes
- Accuracy for molecular subtype diagnosis of invasive breast cancer(Day 1, at time of diagnosis)
- Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma(Day 1, at time of diagnosis)