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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01351974 |
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Date of registration:
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10/05/2011 |
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Primary sponsor: |
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Public title:
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Sentinel Node Biopsy in Breast Cancer Patients
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Scientific title:
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Cohort Study of Axillary Recurrences and Survival After Negative Negative Sentinel Node Biopsy Without Completion Axillary Clearance |
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Date of first enrolment:
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September 2000 |
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Target sample size:
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3369 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01351974 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Leif Bergkvist, M.D. Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Clinical Research, Uppsala University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary invasive breast cancer
Exclusion Criteria:
- Preoperatively diagnosed axillary metastases
- Multifocal tumors
- Tumors > 3 cm
- Impalpable tumors
- Earlier resection of the tumor
- Neoadjuvant treatment
- Pregnancy
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Recurrence
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Primary Outcome(s)
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Axillary recurrence after negative sentinel node biopsy
[Time Frame: 5 years]
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Secondary Outcome(s)
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Survival
[Time Frame: 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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