NCT02688725

Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	post mastectomy ultrasound	post mastectomy ultrasound

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-02-23
• Last updated: 2019-08-28

Locations

1 site across 1 country: United States