Clinical trial · Interventional
Automated Method for Breast Cancer Detection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate FNA samples (low cell counts)
Summary
Brief summary (as posted)
Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Diagnosis | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer Detection cartridge | Device | — | UNRESOLVED |
| Fine needle aspiration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Fine Needle Aspiration
- description
- Participants will receive fine needle aspiration (FNA) later read by the cytopathologist and the cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis).
- interventionNames
- Procedure: Fine needle aspiration
- Device: Cancer Detection cartridge
Primary outcomes (2)
- measure
- Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
- timeFrame
- up to 2 years
- description
- Number of participants in whom DNA methylation profile of 10 genes in the Cancer Detection cartridge correlates with diagnosis based on the gold standard of histopathology of the core biopsy or resected sample.
- measure
- Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be female * Patient must be 18 years of age or older * Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion Exclusion Criteria: * Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).
References
Publications (0)
Data not yet available