Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

August 27, 2019 updated by: Providence Health & Services

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
post mastectomy ultrasound
Device: post mastectomy ultrasound
post mastectomy ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
Time Frame: 3 years
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound during a three year trial period.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured.
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Investigators

  • Principal Investigator: Steve Martinez, MD, MAS,FACS, Providence Health & Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5617S-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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