Tomosynthesis Versus Digital Mammography in a Population-based Screening Program
NCT ID: NCT02590315
Last Updated: 2019-01-31
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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UNKNOWN
PHASE4
92000 participants
INTERVENTIONAL
2014-12-31
2021-12-31
Brief Summary
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This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.
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Detailed Description
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An invitation letter to participate in a randomised screening trial comparing DBT versus DM will be mailed to all women, 46-68 years old, living in the Piedmont Region, and eligible for invitation to the regional mammography screening program. Women who attend the centres for screening and consent to the study will be randomly allocated either to DBT or DM arm.
Women in the DM arm will be screened with bilateral, two-views digital mammography examination. Women in the DBT arm will be screened with the bilateral two-views combo mode (DM and DBT images acquired in a single compression). In both screening arms, examinations will be independently read by two expert screening radiologists. In the DBT arm, each reading will be randomly allocated (on a per-case basis) to one of these three modes: DM plus DBT (DBT is read only after initial DM interpretation), DBT plus DM (DM is read only after DBT interpretation) and "concurrent mode" (both DBT and DM are read simultaneously).
In both screening arms, participants will be recalled for further examination if indicated by at least one radiologist (without consensus or arbitration). At the subsequent round all participants will be invited to DM only. Interval cancers and advanced cancers screen-detected at the next round will be recorded. Pathological and biological parameters of screen-detected cancers (e.g, stage, grading, hormone receptors, HER2) in both screening arms will be measured to investigate overdiagnosis.
With a sample size of 23,000 and 69,000 women in the DBT and DM arm respectively, the investigators will be able to observe a significant decrease in interval cancers and advanced cancers rate of at least 50% (power 80%, two tails). The collected data will be also used to perform analyses on radiological work-flow and workload, and cost-outcome and cost-effectiveness.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Digital Breast Tomosynthesis - DBT
Invitation for breast screening and random allocation. Participants randomised to DBT will be screened with bilateral, two-view combo mode (DBT images are obtained with DM images). DBT participants will have an additional radiation exposure for the combined DM and DBT examinations.
Invitation for breast screening and random allocation
Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
DBT
Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.
Conventional digital mammography - DM
Invitation for breast screening and random allocation. Participants randomised to DM will be screened with bilateral, two-view DM.
Invitation for breast screening and random allocation
Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
Conventional digital mammography.
Conventional digital mammography.
Interventions
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Invitation for breast screening and random allocation
Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
DBT
Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.
Conventional digital mammography.
Conventional digital mammography.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* A terminal illness
* Patients who are unable to give informed consent
* Breast implants
46 Years
68 Years
FEMALE
No
Sponsors
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Regione Piemonte
OTHER
im3D S.p.A.
OTHER
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
OTHER
Responsible Party
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Principal Investigators
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Alfonso Frigerio, Dr
Role: PRINCIPAL_INVESTIGATOR
SCDO Epidemiologia dei Tumori, AOU Città della Salute e della Scienza di Torino
Locations
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Senologia Di Screening - Sscvd
Turin, Piedmont, Italy
Countries
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Other Identifiers
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CPO-PROTEUSDONNA
Identifier Type: -
Identifier Source: org_study_id
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