Breast Cancer Clinical Trial
— SMARTOfficial title:
Stockholm Mammography Risk Stratified Trial
SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months.
Status | Not yet recruiting |
Enrollment | 70000 |
Est. completion date | April 8, 2032 |
Est. primary completion date | April 8, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 74 Years |
Eligibility | Inclusion Criteria: - Have read, understood and signed the informed consent - Perform breast cancer screening at Södersjukhuset - Females in the age range 40 - 74 years at baseline mammography - Using a smartphone or tablet with BankID Exclusion Criteria: - Pregnant, breast feeding or planning to become pregnant. - Previous breast cancer - A medical condition that according to the responsible physician would negatively affect the health of the women. - Cognitive impairment and / or language ability that would make it difficult for the participant to understand the implication of study and to perform a contrast mammography. For women that will be offered contrast enhanced mammography the clinically accepted and applied exclusion criteria will be used. Women who cannot perform a contrast mammography will be offered an automated ultrasound. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Karolinska Institutet |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of biopsies | Information on number of biopsies in recalled women. | 24-month | |
Other | Breast cancer | Y/N , if yes:date of diagonosis. | 24-month | |
Other | Tumor characteristics - Stage | Breast cancer stage 0-4 | 24-month | |
Other | Tumor characteristics - Multifocality | Unifocal or multifocal | 24-month | |
Other | Tumor characteristics - Receptor status | Hormone Receptor Status, to assess the presence of estrogen receptors (ER) and progesterone receptors (PR). HER2 Status, is used to determine whether the cancer cells overexpress the HER2 protein. | 24-month | |
Other | Tumor characteristics - Proliferation | Ki-67 Index, provides information about the tumor's proliferative activity. | 24-month | |
Other | Cancer worry | Measurement of cancer worry will be done by using answers from the self-reported Cancer Worry Scale (8-item CWS). 8-item CWS measure cancer worry, score with Likert scale response, four options from min to max cancer worry. |
24-month | |
Other | Cancer anxiety | Measurement of cancer anxiety will be done by using answers from the self-reported State Trait Anxiety Inventory (STAI-6). STAI-6 measure anxiety. Questions rated on a 4-point Likert scale, options scores from "Not at all" to "Very much" anxiety. |
24-month | |
Other | Side effects related to contrast enhanced mammography | The possible side effects related to contrast enhanced mammography and ordinary mammography will be identified using the self-reported Test Morbidity Index. | 24-month | |
Other | Cost-effectiveness | Cost-effectiveness will be presented in incremental cost-effectiveness ratio (ICER). | 24-month | |
Other | Willingness-to-pay | Willingness-to-pay is defined as the maximum amount that society is willing to pay for each quality adjusted life year (QALY). One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. Scores range from 1 (perfect health) to 0 (dead). | 24-month | |
Primary | Incidence of interval cancers | For women at high 2-year risk in the intervention arm interval cancers are defined as cancers diagnosed in the interval between CEM and 12-month mammogram plus in the interval between 12- and 24-month interval. For the remaining women in the trial interval cancers are defined as cancers diagnosed between baseline mammography and 24-month mammography. | 24-month | |
Secondary | Number of recalled women | Information on number of women recalled from screening mammography. | 24-month |
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