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NCT03863522 · ClinicalTrials.gov registry record · NA
Automated Method for Breast Cancer Detection
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- NA
- Development phase
- 116
- Enrollment target
NCT03863522: Clinical Trial NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03863522 is a NA study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 116 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03863522, a NA study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- NA
- Development phase
- 116 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- PROCEDURE Fine needle aspiration
- DEVICE Cancer Detection cartridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2019-03-07 |
| Est. Completion | 2020-12-15 |
| Phase | NA |
Why NCT03863522 stopped before completion
NCT03863522 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Fine needle aspiration is the first listed.
NCT03863522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03863522 about?
NCT03863522 is a clinical study titled "Automated Method for Breast Cancer Detection". 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...
What is the current status of trial NCT03863522?
This trial is currently terminated. It is a NA study. The enrollment target is 116 participants. The study started on 2019-03-07. Estimated completion is 2020-12-15.
What interventions are being tested in trial NCT03863522?
The interventions under investigation include: Fine needle aspiration (PROCEDURE), Cancer Detection cartridge (DEVICE).
Who is sponsoring clinical trial NCT03863522?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03863522's enrollment target sits among peer trials
116 808th of 2000 higher than 1,191 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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