STEP: Study of Tumor Educated Platelets for early detection of breast cancer in blood in BRCA1/2 mutation carriers

STEP: Study of Tumor Educated Platelets for early detection of breast cancer in blood in BRCA1/2 mutation carriers - STEP: early detection of breast cancer in blood

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55545

Enrollment

875

Registered

2017-09-25

Start date

2018-01-12

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Breast cancer mammary carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female sex - 25-70 years of age - carrier of a pathogenic BRCA1/2 mutation - under regular surveillance for their first BrCa

Exclusion criteria

Exclusion criteria: - previous history of cancer, except basal cell carcinoma and precursor lesions of cervical cancer - previous preventive bilateral mastectomy - intellectual disability

Design outcomes

Primary

Measure	Time frame
- The sensitivity and specificity of the Med-Seq test for detection of breast cancer in this specific cohort of female BRCA1/2 mutation carriers in an early stage. - The proportion of female BRCA1/2 mutation carriers in whom the MeD-seq test detected breast cancer significantly more early (i.e. 1 year) than current surveillance tools.	—

Countries

Netherlands

Outcome results