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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002051-34 | Other Identifier | IDRCB number (ANSM) |
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This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast cancer histologically proven | Active Comparator | Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment |
|
| surveillance of a treated breast cancer | Active Comparator | surveillance of patient already treated for breast cancer must have annual mammography |
|
| diagnosis of a detected anomaly | Active Comparator | patient addressed for diagnosis of a detected anomaly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tomosynthesis | Device | 2 incidences 3D numeric mammography |
|
| Measure | Description | Time Frame |
|---|---|---|
| determine the benefit of tomosynthesis for diagnosis | number of avoided focused cliches and ultrasound, after tomosynthesis analysis | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| determine best incidence of realization | face, medial side or oblique | 30 months |
| measurement of breast irradiation | comparison of tomosynthesis irradiation and focused cliches irradiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie TAIEB, MD | Oscar Lambret Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oscar Lambret Center | Lille | 59020 | France | |||
| Centre Hospitalier - Pavillon Paul Gelé |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 2D mammography | Device | 2 incidences 2D analogic mammography |
|
| 30 months |
| evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast | 30 months |
| number of additional cancer detected by tomosynthesis | number of breast cancer detected through tomosynthesis | 30 months |
| Roubaix |
| 59100 |
| France |
| Centre Hospitalier | Valenciennes | 59300 | France |
| Clinique des Dentellières | Valenciennes | 59300 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |