Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02688725
• Other study ID #: 5617S-14
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2019
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• post mastectomy ultrasound
post mastectomy ultrasound

Locations

Country	Name	City	State
United States	Providence Regional Cancer Partnership	Everett	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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.	3 years