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Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients

NCT00783822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2012-11-09

No results posted yet for this study

Summary

5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic counseling and DNA testing are usually offered to selected patients after primary treatment has been completed (e.g. the first year after diagnosis). For women with a mutation in one of the two breast-ovarian cancer syndrome genes, chances of a second breast cancer are high, and therefore a proportion of these women may opt for preventive measures in addition to their immediate breast cancer treatment. Contralateral prophylactic mastectomy significantly reduces this risk, and is associated with a reduction in mortality.

Genetic counseling and testing for breast cancer typically takes approximately 4-6 months to complete. However, some hospitals and laboratories are now able to generate test results within 3 to 6 weeks. This technology of rapid genetic testing creates new opportunities for providing both women and their treating surgeons with information potentially relevant for deciding between available treatment options, including type of surgery and adjuvant therapy.

The study will focus on newly diagnosed breast cancer patients who, prior to receiving treatment, are identified as having at least a 10% risk of carrying a mutation in the BRCA1 or BRCA2 genes.

We will investigate whether women with a recent diagnosis of breast cancer make use of rapid genetic counseling when offered.

Furthermore, we will investigate whether the process of genetic counseling (and subsequent DNA testing) has influence on the choice of treatment, and whether and how such rapid genetic counseling and testing (RGCT) affects levels of risk perception, cancer-related worries and distress, and decisional satisfaction.

Conditions

  • Breast Neoplasms

Interventions

OTHER

RGCT

rapid genetic counseling and testing

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Fonds NutsOhra

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • N. K. Aaronson, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-01-31
Completion
2012-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00783822 on ClinicalTrials.gov