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| Name | Class |
|---|---|
| AULSS 9 Scaligera di Verona | UNKNOWN |
| IRCCS Policlinico S. Donato, Milano | UNKNOWN |
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
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Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.
This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.
In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).
The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.
The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.
Women will be asked for informed consent when they attend the mammography. If they accept they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomosynthesis + synthetic 2D | Experimental | Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. |
|
| Digital Mammography | Active Comparator | Women will be screened for digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tomosynthesis + synthetic 2D | Diagnostic Test | Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. |
| Measure | Description | Time Frame |
|---|---|---|
| advanced cancer incidence | cumulative incidence of T2+ cancers after first screening round | 2 years (+9 months to complete second round assessment) |
| advanced cancer incidence | cumulative incidence of T2+ cancers after first screening round | 4 years (+9 months to complete third round assessment) |
| interval cancer incidence | incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome. | 2 years for 50-65 years old women |
| interval cancer incidence | incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome. | 1 year for 45-49 years old women |
| Measure | Description | Time Frame |
|---|---|---|
| overall cumulative incidence | overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography. | 2 years (+9 months to complete second round assessment) |
| overall cumulative incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia | Reggio Emilia | Italy | 42122 | Italy | ||
| IRCCS Policlinico San Donato |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| 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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Women 45-65 participating in the mammographic screening program will be randomized to one round of screening with tomosynthesis + synthetic 2D or with digital mammography. Then all women will be re-screened after 2 years (1 year for women 45-49) for at least one round with digital mammography.
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It is not possible to mask the intervention for the patient, care provider, and investigator.
Only the assessment of one of the two co-primary outcomes, i.e. cumulative incidence of advanced breast cancer after the first round of screening, can be masked. This will be obtained through a blind review of an external panel of pathologists and radiologists reviewing cases retrieved by cancer registries.
|
| digital mammography | Diagnostic Test | Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography. |
|
overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography. |
| 4 years (+9 months to complete second round assessment) |
| detection rate | cancer detected by the screening round on total screened women | This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered |
| recall rate | number of women referred to assessment after the first leve screening test on total screened women | This outcome is measured at the baseline screening. |
| positive predictive value | proportion of cancer among women recalled for assessment | This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered |
| Detection rate of ductal carcinoma in situ | ductal carcinoma in situ detected by the screening round on total screened women | This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered |
| biopsy rate | number of women undergoing biopsy after the first leve screening test on total screened women | This outcome is measured at the baseline screening. |
| x-ray dose | average glandular dose receive by women during first level test | This outcome is measured at the baseline screening. |
| reading time | time needed to read an imaging first level examination | This outcome is measured at the baseline screening. |
| Milan |
| Italy |
| Azienda Ospedaliera Universitaria Integrata | Verona | Italy |
| Azienda Ulss 9 Scaligera | Verona | Italy |
| D017437 |
| Skin and Connective Tissue Diseases |