Trial no.:
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PACTR202111860919273 |
Date of Approval:
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26/11/2021 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Validation study for rapid profiling of immunohistochemical markers for breast cancer |
Official scientific title |
Feasibility and accuracy of nanosensor-based breast cancer diagnosis at the point-of-care-
AIKILI technology |
Brief summary describing the background
and objectives of the trial
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One of the biggest cancer challenges in low- and middle-income countries (LMICs) is the lack of access to accurate and affordable cellular and molecular diagnostics, which are essential for making informed therapeutic decisions, in particular for breast cancer. With the increased use of low cost ultrasound, it has become possible to readily sample suspicious breast lesions with fine needles (fine needle aspirates, FNA). However, the workup of such specimens is often challenging. To address these barriers to diagnosis, Aikili Biosystems seeks to enable the same-day diagnostic profiling of breast cancer at the point-of-care using a low-cost, automated system. Building upon initial development and successful clinical validation of human
samples, the goal of this study is to further validate the Aikili technology for use in automated immunohistochemical workup. Specifically, we propose to evaluate the performance of our system to reliably detect breast cancer receptor and HER2 status in
human FNAs compared to accepted gold standards (n=40). |
Type of trial |
CCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Cancer |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Diagnosis / Prognosis |
Anticipated trial start date |
01/12/2021 |
Actual trial start date |
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Anticipated date of last follow up |
30/04/2022 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
40 |
Actual target sample size (number of participants) |
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Recruitment status |
Not yet recruiting |
Publication URL |
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