Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111860919273 Date of Approval: 26/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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 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)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2021
Actual trial start date
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Gold standard histopathology and IHC n/a - diagnostic profiling study n/a Study participants will receive gold standard histopathology and immunohistochemistry diagnosis of breast masses. 40 Uncontrolled
Experimental Group FNA immunohistochemistry workup n/a n/a Study participants, in addition to gold standard pathology/IHC diagnosis, will also undergo fine needle aspiration of suspected breast masses. The associated FNA samples will be analyzed for HER2 and hormone receptor status using Aikili's automated image cytometry technology. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult female patients with known or suspected breast malignancy being referred for biopsy of the suspicious lesion. Women with metastatic breast cancer and who will undergo treatment in the subsequent 2 weeks for recurrent disease with either cytotoxic and/or targeted therapies. Women with metastatic breast cancer with any prior chemotherapy regimen or never treated allowed. Women with metastatic breast cancer who must be able to understand and sign an informed consent. Children defined as patients under 18 years of age Patients not pursuing cancer treatment / monitoring at Aga Khan University Hospital 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/01/2021 Institutional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, Limuru Road Nairobi GPO 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome We will evaluate whether the Aikili system for diagnostic profiling of breast FNA samples accurately and reliably detects breast cancer and receptor status in human FNAs compared to accepted gold standards. Our primary outcome is to assess whether the Aikili system achieves >90% congruency with gold standard pathology and immunohistochemistry workups, in order to match the sensitivity and specificity of current workflows at Aga Khan. Within 1 month of obtaining tissue and FNA samples, following diagnostic profiling of FFPE and FNA samples
Secondary Outcome Correlation of breast FNA profiling for HER2 and ER/PR using Aikili diagnostic technology with results from flow cytometry Within 1 month of obtaining FNA samples
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands Avenue, Limuru Road Nairobi na Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Cancer Institute of National Institute of Health 9609 Medical Center Drive Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aikili Biosystems Inc. 127 Western Ave Allston MA 02134 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Shahin Sayed MBChB MMED Aga Khan University Hospital, 3rd Parklands Avenue Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Laura Kelley lkelley@aikilibio.com +16178999838 127 Western Ave
City Postal code Country Position/Affiliation
Allston 02134 United States of America Trial sponsor company
Role Name Email Phone Street address
Principal Investigator Shahin Sayed shaheen.sayed@aku.edu +254733719045 Aga Khan University Hospital
City Postal code Country Position/Affiliation
Nairobi Kenya Assoc. Chair Pathology Department
Role Name Email Phone Street address
Scientific Enquiries Laura E Kelley lkelley@aikilibio.com +16178999838 Harvard Innovation Lab
City Postal code Country Position/Affiliation
Allston 02134 United States of America Corporate Development
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data may be available to other researchers, for example, if study results are accepted for publication Statistical Analysis Plan,Study Protocol Following publication, for 36 months. Individual participant data that underlie the results reported by a potential publication may be shared, following de-identification.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information