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

Recruiting

• Conditions: 10006291; Breast cancer; mammary carcinoma; 10083624

• Registration Number: NL-OMON55545
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 875

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>