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

Primary Purpose

Breast Neoplasms, Lymphoma

Status
Completed
Phase
Not Applicable
Locations
Botswana
Study Type
Interventional
Intervention
Contrast Microhalography (CEM)
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Botswana Harvard AIDS Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard diagnosis and CEM platform

Arm Description

Participants will receive standard diagnostic approach and assessment by CEM platform

Outcomes

Primary Outcome Measures

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.
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.
Time to diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Proficiency in testing using CEM platform
Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 4, 2019
Last Updated
April 26, 2022
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
National Cancer Institute (NCI), Botswana Harvard AIDS Institute Partnership, Massachusetts General Hospital, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04119154
Brief Title
Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Acronym
Chedza
Official Title
Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
National Cancer Institute (NCI), Botswana Harvard AIDS Institute Partnership, Massachusetts General Hospital, Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Lymphoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
Masking
None (Open Label)
Masking Description
No masking, open label.
Allocation
N/A
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard diagnosis and CEM platform
Arm Type
Experimental
Arm Description
Participants will receive standard diagnostic approach and assessment by CEM platform
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast Microhalography (CEM)
Intervention Description
Fine needle aspirates evaluated by CEM device
Primary Outcome Measure Information:
Title
Accuracy for diagnosis of non-Hodgkin lymphoma
Description
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Time Frame
Day 1, at time of diagnosis
Title
Accuracy for diagnosis of invasive breast cancer
Description
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Time Frame
Day 1, at time of diagnosis
Title
Time to diagnosis
Description
Time from diagnostic procedure to knowledge of test result by the treating clinician
Time Frame
Day 1, at time of diagnosis
Title
Proficiency in testing using CEM platform
Description
Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform
Time Frame
Day 1, At completion of training
Secondary Outcome Measure Information:
Title
Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma
Description
Accuracy (proportion of true positive and true negative out of total number non-Hodgkin lymphoma) of CEM in comparison with standard diagnostic approach.
Time Frame
Day 1, at time of diagnosis
Title
Accuracy for molecular subtype diagnosis of invasive breast cancer
Description
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.
Time Frame
Day 1, at time of diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Weissleder, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Dryden-Peterson, MD, MSc
Organizational Affiliation
Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Botswana Harvard AIDS Institute
City
Gaborone
Country
Botswana

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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