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

President and Fellows of Harvard College

Status: Completed

Conditions: Lymphoma; Breast Neoplasms

Treatments: Diagnostic Test: Contrast Microhalography (CEM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04119154

BHP0111

UH3CA202637 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

Standard diagnosis and CEM platform

Experimental group

Description:

Participants will receive standard diagnostic approach and assessment by CEM platform

Treatment:

Diagnostic Test: Contrast Microhalography (CEM)