Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:December 2014
End Date:January 2019

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Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer

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.

Inclusion Criteria:

- must be ≥ 18 years of age.

- histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer
(American Joint Committee on Cancer, 7th edition stage 0, I, II, III, or IV)
-previously treated with mastectomy

Exclusion Criteria:

- pregnant or breast feeding.

- cannot tolerate lying supine for breast ultrasound examination.

- mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive
microcalcifications in the absence of concurrent DCIS or invasive breast cancer
We found this trial at
1
site
1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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mi
from
Everett, WA
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