An observational study in Atypical Ductal Hyperplasia (ADH) of the Breast, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by Yale University · Observational
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.
We hypothesize that surgical excision may not yield an improvement in survival over hormonal therapy and/or close observation alone in patients who present with ADH on core needle biopsy of the breast. An alternate (non-inferior) strategy for management may be possible, and may be associated with improved quality of life and fewer complications, and lower overall costs. Although several researchers have suggested a clinical trial to investigate this idea this would be the first time it has been done, and could therefore be practice changing.
205 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 46 are open to participants now.
This study's enrollment of 9 is below the median of 200 across 39 observational studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Patients presenting to the Breast Clinic at Smilow for evaluation and management of ADH will be identified. After screening and informed consent, patient demographics and study specific data points will be obtained by interview and chart review. Patients will then be randomized to surgical excision or close observation.
A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
Exclusion Criteria
A patient/subject will not be eligible for this study if any of the following exclusion criteria are met:
Findings of palpable mass or imaging abnormality (increase in size or in the amount of calcifications)
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 clinical breast exam and yearly breast imaging.
Time frame: 5 years
Quality of life, patient satisfaction and costs between the two groups will be measured by the Functional Assessment of Chronic Illness Therapy (FACIT), specifically the FACT-G and the FACT-Es.
The FACT-GP will measure physical well-being, social/family well-being, emotional well-being and functional well-being. Higher scores indicate better well-being. The FACT-Es will be used to assess symptoms related to menopause and tamoxifen or exemestane, as we anticipate many of the subjects will be on endocrine therapy as part of their chemo-prevention.
Time frame: 5 years
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Carcinoma, Intraductal, Noninfiltrating→
Yale University