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Main
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Note: This record shows only 22 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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12 December 2020 |
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Main ID: |
NCT01612650 |
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Date of registration:
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04/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
TOMOSEIN |
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Scientific title:
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Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis |
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Date of first enrolment:
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February 24, 2012 |
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Target sample size:
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1069 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01612650 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Sophie TAIEB, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oscar Lambret Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- woman with breast cancer histologically proven (group 1), on surveillance of a treated
breast cancer (group 2) or diagnosis of an detected anomaly
- age = 40 years (group 1, group 2); age = 50 years (group 3)
- breast size suitable for detector size
- possible prior mastectomy
- security social covered
- signed informed consent
Exclusion Criteria:
- breast implant
- high genetic risk (mutation)
- under justice measures
- breast feeding or pregnant woman
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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3D Mammography
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2D Mammography
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Breast Cancer
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Intervention(s)
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Device: 2D mammography
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Device: tomosynthesis
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Primary Outcome(s)
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determine the benefit of tomosynthesis for diagnosis
[Time Frame: 30 months]
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Secondary Outcome(s)
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determine best incidence of realization
[Time Frame: 30 months]
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evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
[Time Frame: 30 months]
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number of additional cancer detected by tomosynthesis
[Time Frame: 30 months]
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measurement of breast irradiation
[Time Frame: 30 months]
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Secondary ID(s)
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2011-002051-34
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TOMOSEIN-1104
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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