Surveillance Imaging Modalities for Breast Cancer Assessment

NCT02212834 | Completed Results

• 1 other identifier: CE-1304-6656
• Study Type: observational
• Target: 36,444
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effectiveness of surveillance breast MRI compared to mammography alone in women with a personal history of breast cancer

Conditions

Breast Cancer

Keywords

Breast; Cancer; Surveillance; Imaging; Comparative; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Number of Breast Cancers Detected

  Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI

  12 months post surveillance exam

Study Arms (2)

Mammograms

Surveillance mammograms in women with a personal history of breast cancer

Breast MRI

Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surveillance imaging exams in women included in the Breast Cancer Surveillance Consortium who are 18+ years of age at the the of a Stage 0-III incident breast cancer diagnosis between January 1, 2005 and December 31, 2012.

You may not qualify if:

• Women with a diagnosis of lobular carcinoma in situ
• Women with missing cancer staging data from Surveillance, Epidemiology and End Results (SEER) Program records
• Women with Stage 4 breast cancer at time of diagnosis
• Women with a diagnosis of a second breast cancer event within six months of the primary diagnosis
• Women who die within six months of primary diagnosis
• Women who have had a double mastectomy

Sponsors & Collaborators

• Kaiser Permanente: lead
• Dartmouth College: collaborator
• Harvard Pilgrim Health Care: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of California, San Francisco: collaborator
• University of Wisconsin, Madison: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Related Publications (3)

• Johnson DS, Bush MT, Brandzel S, Wernli KJ. The patient voice in research-evolution of a role. Res Involv Engagem. 2016 Feb 22;2:6. doi: 10.1186/s40900-016-0020-4. eCollection 2016.

  PMID: 29062507 BACKGROUND

• Henderson LM, Ichikawa L, Buist DSM, Lee JM, Bush M, Johnson D, Onega T, Nekhlyudov L, Kerlikowske K, Miglioretti DL, Sprague BL, Wernli KJ. Patterns of Breast Imaging Use Among Women with a Personal History of Breast Cancer. J Gen Intern Med. 2019 Oct;34(10):2098-2106. doi: 10.1007/s11606-019-05181-6. Epub 2019 Aug 13.

  PMID: 31410813 BACKGROUND

• Wernli KJ, Ichikawa L, Kerlikowske K, Buist DSM, Brandzel SD, Bush M, Johnson D, Henderson LM, Nekhlyudov L, Onega T, Sprague BL, Lee JM, Lehman CD, Miglioretti DL. Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. Radiology. 2019 Aug;292(2):311-318. doi: 10.1148/radiol.2019182475. Epub 2019 Jun 4.

  PMID: 31161975 RESULT

Related Links

• SIMBA Decision tool
• Video of impact of patient engagement in research
• Home page for the Breast Cancer Surveillance Consortium

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

This study was not a clinical trial. It was a cohort analysis of existing data.

Results Point of Contact

• Title: Karen J. Wernli, PhD
• Organization: Group Health Research Institute

wernli.k@ghc.org

206-287-2934

Study Officials

• Karen J. Wernli, PhD

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: August 8, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 22, 2024
• Results First Posted: February 7, 2017

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share