Breast Density as Indicator for the Use of Mammography or MRI to Screen Women with Familial Risk for Breast Cancer: a RCT.

Breast Density as Indicator for the Use of Mammography or MRI to Screen Women with Familial Risk for Breast Cancer: a RCT. - FaMRIsc (is for FAmilial risk MRI SCreening indicated by breast density? )

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43998

Enrollment

2000

Registered

2010-11-08

Start date

2011-01-17

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer neoplasm mammae

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Familial cumulative lifetime breastcancer risk of * 20% according to Claus tables (as used by Genetic Centres) age 30-55 yrs.

Exclusion criteria

Exclusion criteria: BRCA1 or BRCA2 mutation carrier or 50% risk of being one. Personal history of breast cancer Breast MRI contra-indication like metal implant

Design outcomes

Primary

Measure	Time frame
Primary outcomes are: the numbers of tumours detected at screening examinations and in between screening examinations (interval tumours), and the stage distribution at diagnosis in the different trial arms, with application of density scores for the analyses of results.	—

Secondary

Measure	Time frame
Other outcomes are the sensitivities and proportions of false-positive results. Breast cancer mortality reduction will be estimated using breast cancer microsimulation models (MISCAN). Costs will be calculated per quality adjusted life-year gained.	—

Countries

Netherlands

Outcome results