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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119154
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : May 2, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Botswana Harvard AIDS Institute Partnership
Massachusetts General Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Scott Dryden-Peterson, 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Lymphoma Diagnostic Test: Contrast Microhalography (CEM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
Masking: None (Open Label)
Masking Description: No masking, open label.
Primary Purpose: Diagnostic
Official Title: Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : September 20, 2021
Actual Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Time to diagnosis [ Time Frame: Day 1, at time of diagnosis ]
    Time from diagnostic procedure to knowledge of test result by the treating clinician

  4. 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


Secondary Outcome Measures :
  1. Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma [ Time Frame: 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.

  2. Accuracy for molecular subtype 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 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119154


Locations
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Botswana
Botswana Harvard AIDS Institute
Gaborone, Botswana
Sponsors and Collaborators
Harvard School of Public Health (HSPH)
National Cancer Institute (NCI)
Botswana Harvard AIDS Institute Partnership
Massachusetts General Hospital
Brigham and Women's Hospital
Investigators
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Principal Investigator: Ralph Weissleder, MD, PhD Massachusetts General Hospital
Principal Investigator: Scott Dryden-Peterson, MD, MSc Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Scott Dryden-Peterson, Harvard School of Public Health (HSPH):
Informed Consent Form  [PDF] July 17, 2019

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Responsible Party: Scott Dryden-Peterson, Research Associate, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier: NCT04119154    
Other Study ID Numbers: BHP0111
UH3CA202637 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Completely anonymized data can be shared to investigators following successful receipt of IRB approval (Botswana and US committees).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Following completion of primary analysis.
Access Criteria: Sharing following required IRB approval (Botswana and US).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases