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NCT01925586 · ClinicalTrials.gov registry record
Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 9
- Enrollment target
NCT01925586: Completed study, sponsored by Yale University.
NCT01925586 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925586 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
Study Summary
This study is designed to look at whether it is feasible to observe women with atypical ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.
Primary Outcome
Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications) in the observation period will be subject to biopsy; pathology results indicating in situ or invasive disease will prompt multi-disciplinary treatment consistent with established standards of care.Patients in the close observation group will be assessed at six months and annually thereafter with clinical examination and breast imaging. Patients in the surgery group will be followed with yearly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-08 |
What the finished NCT01925586 record still lists
NCT01925586 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01925586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01925586 about?
NCT01925586 is a clinical study titled "Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)". This study is designed to look at whether it is feasible to observe women with atypical ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.
What is the current status of trial NCT01925586?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2013-08. Estimated completion is 2018-08.
Who is sponsoring clinical trial NCT01925586?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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