Cancer
Conditions
Interventions
Gold standard histopathology and IHC
FNA immunohistochemistry workup
Sponsors
Aikili Biosystems Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Children defined as patients under 18 years of age Patients not pursuing cancer treatment / monitoring at Aga Khan University Hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of breast FNA profiling for HER2 and ER/PR using Aikili diagnostic technology with results from flow cytometry | — |
Countries
Kenya
Contacts
Public ContactLaura Kelley
Trial sponsor company
Outcome results
None listed