An interventional study of post mastectomy ultrasound in Breast Cancer, sponsored by Providence Health & Services. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Providence Health & Services · Not applicable, Interventional, and Screening
Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.
The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims:
Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence.
Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Providence Health & Services is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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Exclusion Criteria:
post mastectomy ultrasound
Device: post mastectomy ultrasound
post mastectomy ultrasound
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound during a three year trial period.
Time frame: 3 years
The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured.
Sensitivity measures the proportion of patients that have pathologically confirmed breast cancer recurrences that were correctly identified as such by surgeon performed ultrasound.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Providence Health & Services