Skip to content

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

Hereditary breast cancer and the clinical significance of variants in the BRCA1 and BRCA2 genes. - Hereditary breast cancer and DNA Unclassified Variants.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37491
Enrollment
270
Registered
2012-10-16
Start date
2012-12-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

hereditary breast cancer mamma carcinoma

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Niet applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)