Clinical trial NCT04119154: Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Official title: Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lymphoma
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Botswana Harvard AIDS Institute Partnership
name: Massachusetts General Hospital
name: Brigham and Women's Hospital
First posted: 2019-10-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Accuracy for diagnosis of non-Hodgkin lymphoma
timeFrame: Day 1, at time of diagnosis
measure: Accuracy for diagnosis of invasive breast cancer
timeFrame: Day 1, at time of diagnosis
measure: Time to diagnosis
timeFrame: Day 1, at time of diagnosis
measure: Proficiency in testing using CEM platform
timeFrame: Day 1, At completion of training
Secondary outcomes:
measure: Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma
timeFrame: Day 1, at time of diagnosis
measure: Accuracy for molecular subtype diagnosis of invasive breast cancer
timeFrame: Day 1, at time of diagnosis
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard AIDS Institute
Study officials:
affiliation: Massachusetts General Hospital
name: Ralph Weissleder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital
name: Scott Dryden-Peterson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: