Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Dec 2014
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 29, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 28, 2019
August 1, 2019
5 years
December 29, 2015
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured.
3 years
Study Arms (1)
Ultrasound
EXPERIMENTALpost mastectomy ultrasound
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Martinez, MD, MAS,FACS
Providence Health & Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2015
First Posted
February 23, 2016
Study Start
December 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share