Hereditary breast cancer and the clinical significance of variants in the BRCA1 and BRCA2 genes.

Recruiting

Conditions: hereditary breast cancer
mamma carcinoma
10083624
10006291

Registration Number: NL-OMON37491

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 270

Inclusion Criteria

1) UV-cohort: patients who are carrier of an unclassified variant.
2) Affected relatives of the UV-cohort patients will be invited for this study.
3) At least one non-affected family member of the UV-cohort patients will be invited to take part in this study. ;The UV-cohort consists of patients diagnosed with a primary breast tumor before the age of 60 years and are unrelated.
The patient can be included if only one unclassified variant is found in the BRCA1 or BRCA2 gene.
All the participants should be older than 18 years, competent and independent of the researcher.
They should all be informed about the study, its goal and its duration.
They know about the possibility of interim quitting the study.

Exclusion Criteria

- Younger than 18 years old and older than 60 years old. Not affected family members may however, be older than 60 years old.
-The participants should be competent to be able to make decision about participation.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Following the KGCL protocol (Klinisch Genetisch Centrum Leiden), all the<br /><br>affected family members of the patient will be tested on the presence of the<br /><br>Unclassified Variant. Furthermore, also at least one older not affected family<br /><br>member should be tested. This information helps to understand more about the<br /><br>association between carrying a variant and developing cancer. </p><br>

Secondary Outcome Measures