Breast Cancer Clinical Trial
— MISSOfficial title:
What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer
Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
Status | Recruiting |
Enrollment | 60000 |
Est. completion date | February 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 49 Years |
Eligibility | Inclusion Criteria: 1. Women invited for their first or second mammography (45 or 46 y/o) presenting for screening; 2. Willingness and ability to comply with scheduled visits; 3. Written informed consent obtained prior to performing any protocol-related procedures. Exclusion Criteria: 1. Pregnancy status; 2. Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis; 3. Ascertained heredo-familial risk according to the standard family history used in screening programs; 4. Participation in another clinical trial on BC screening; 5. Inability to provide signed informed consent. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO) | Firenze | |
Italy | AUSL Romagna | Forlì | |
Italy | Irst Irccs | Meldola (FC) | FC |
Italy | AOU Città della Salute e della Scienza | Torino |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals | Cumulative breast cancer risk will computed as the ratio between the number of stage 2 or higher cancers and the total number of women in the arm. The comparison between arms will be performed using the two proportion Z-test. 95% confidence intervals will also be computed | 6 years | |
Secondary | Participation in screening | number of participating women within 3 months since invitation)/(total invited women). It will be computed for each screening round and overall as average of round participation | 6 years | |
Secondary | contamination proportion (use of mammography) within two screening rounds (in women referred to 2-year interval) | number of women referred to 2-year interval and performing a mammogram within two screening round)/number of women referred to 2-year interval The indicator will be computed only for women randomized to arm 2 and for women referred to 2-year arm in arm 3 | 6 years | |
Secondary | Breast cancer detection | number of women with BC diagnosis at screening / number of total screened women | 6 years | |
Secondary | overall recall rate | number of women recalled for further assessment/ number of total screened women. | 6 years | |
Secondary | rate of recall with an invasive procedure (biopsy) | number of women recalled for further assessment with a biopsy/ number of total screened women | 6 years | |
Secondary | interval Breast Cancer rate | number of cancers occurring after a negative mammography and before the date of the next planned appointment/ number of total screened women | 6 years | |
Secondary | cumulative Breast Cancer incidence | Cumulative incidence of BC including baseline test | 6 years | |
Secondary | resource expenditure | Mean costs for each attending woman in every of the following processes: Coordination and organization; Invitation; First level mammography; Diagnostic assessment (invasive and non invasive) |
6 years | |
Secondary | prevalence of dense breast in the target population | women with BI-RADS A, B, C, and D/total women included in the tailored arm | 6 years |
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