A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
NCT ID: NCT01452399
Last Updated: 2021-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
251 participants
INTERVENTIONAL
2011-10-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Shave Margins
Shave margins
Partial mastectomy with shave margins.
No shave margins
No Shave Margins
Partial mastectomy without shave margins.
Interventions
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Shave margins
Partial mastectomy with shave margins.
No Shave Margins
Partial mastectomy without shave margins.
Eligibility Criteria
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Inclusion Criteria
2. Women ≥ 18 years of age.
3. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Patients who require a total mastectomy
3. Known metastatic breast cancer.
18 Years
90 Years
FEMALE
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Anees Chagpar, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Breast Center -- Smilow Cancer Hospital at Yale-New Haven
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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References
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Chagpar AB, Horowitz NR, Killelea BK, Tsangaris T, Longley P, Grizzle S, Loftus M, Li F, Butler M, Stavris K, Yao X, Harigopal M, Bossuyt V, Lannin DR, Pusztai L, Davidoff AJ, Gross CP. Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial. Ann Surg. 2017 Jan;265(1):39-44. doi: 10.1097/SLA.0000000000001799.
Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.
Other Identifiers
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1107008825
Identifier Type: -
Identifier Source: org_study_id
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