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

Not Applicable

Completed

• Conditions: Breast Neoplasms; Lymphoma
• Interventions: Diagnostic Test: Contrast Microhalography (CEM)

• Registration Number: NCT04119154
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-05
• Study First Posted: 2019-10-08
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard diagnosis and CEM platform	Contrast Microhalography (CEM)	Participants will receive standard diagnostic approach and assessment by CEM platform

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Botswana Harvard AIDS Institute; 🇧🇼 Gaborone, Botswana