Back to resultsPost-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
post mastectomy ultrasound
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Providence Regional Cancer Partnership
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound
Arm Description
post mastectomy ultrasound
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02688725
First Posted
December 29, 2015
Last Updated
August 27, 2019
Sponsor
Providence Health & Services
1. Study Identification
Unique Protocol Identification Number
NCT02688725
Brief Title
Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients
Official Title
Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
post mastectomy ultrasound
Intervention Type
Device
Intervention Name(s)
post mastectomy ultrasound
Intervention Description
post mastectomy ultrasound
Primary Outcome Measure Information:
Title
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
Description
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
Secondary Outcome Measure Information:
Title
The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured.
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Martinez, MD, MAS,FACS
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients
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