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Improving risk estimates for familial breast cancer

Improving risk estimates for familial breast cancer - Improving risk estimates for familial breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33487
Enrollment
600
Registered
2010-02-22
Start date
2011-01-21
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Breast cancer

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient has an elevated risk to develop breast cancer on the basis of her family history for the disease - Patient has been tested for DNA mutations in BRCA1 and BRCA2 - If patient is known with breast cancer, she has at least two first- or second degree relatives with breast cancer - If patient has no personal history of breast cancer, she has at least three first- or second-degree relatives with breast cancer - Families are elible for inclusion if at least two breast cancer patients are alive at the time of ascertainment to donate blood and/or a skin biopsy

Exclusion criteria

Exclusion criteria: 1. Individuals younger than 18 2. Individuals with mental illnesses

Design outcomes

Primary

MeasureTime frame
1. A rare high-risk mutation in a gene that is associated with breast cancer, of relevance to the individual. 2. A common low-risk SNP-variation in a gene that is associated with breast cancer, of relevance to the familial breast cancer group as a whole. 3. A genetic profile that occurs more often among affected family members than among controls (sporadic patients or healthy subjects). 4. An association between the result of a functional assay on cell material of study participants and disease status, at the individual or familial level. 5. A gene expression profile in cell material of study participants that is associated with disease status, at the individual or familial level. 6. A proteomics profile in cell or serum material of study participants that is associated with disease status, at the individual or familial level.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)