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

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

Study Overview

• Status: Completed
• Conditions: Lymphoma; Breast Neoplasms
• Intervention / Treatment: Diagnostic test: Contrast Microhalography (CEM)

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 Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana
    • Botswana Harvard AIDS Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard diagnosis and CEM platform; Participants will receive standard diagnostic approach and assessment by CEM platform	Diagnostic test: Contrast Microhalography (CEM); Fine needle aspirates evaluated by CEM device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: National Cancer Institute (NCI); Massachusetts General Hospital; Brigham and Women's Hospital; Botswana Harvard AIDS Institute Partnership
• Investigators: Principal Investigator: Scott Dryden-Peterson, MD, MSc, Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): September 20, 2021
• Study Completion (ACTUAL): September 20, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 5, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BHP0111; UH3CA202637 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Completely anonymized data can be shared to investigators following successful receipt of IRB approval (Botswana and US committees).
• IPD Sharing Time Frame: Following completion of primary analysis.
• IPD Sharing Access Criteria: Sharing following required IRB approval (Botswana and US).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No