Status:
COMPLETED
Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
National Cancer Institute (NCI)
Botswana Harvard AIDS Institute Partnership
Conditions:
Breast Neoplasms
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04119154
Start Date
August 1 2019
End Date
September 20 2021
Last Update
May 2 2022
Active Locations (1)
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1
Botswana Harvard AIDS Institute
Gaborone, Botswana