Hereditary Breast Cancer Clinical Trial
— BRCAsearchOfficial title:
BRCAsearch: A Population Based Prospective Study on Screening for BRCA1 and BRCA2 Germline Mutations in Patients With Newly Diagnosed Breast Cancer Treated in Southern Sweden.
NCT number | NCT02557776 |
Other study ID # | Dnr 2009/659 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | March 2018 |
Verified date | February 2019 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall purpose of the study is to evaluate a method for offering mutation analysis of BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at diagnosis and family history. Information about the study as well as pre-test genetic counseling will primarily be given in a written way. In addition to that, if a study participant wishes to, she can also receive pre-test telephone genetic counseling.
Status | Completed |
Enrollment | 542 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. The patient is included in the SCAN-B study. 2. The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ. 3. The patient has signed an informed consent form. Exclusion Criteria: 1. The patient is unable to understand the written information in Swedish. 2. The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing. |
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborg Hospital, Dept of Surgergy | Helsingborg | |
Sweden | Kristianstad Central Hospital | Kristianstad |
Lead Sponsor | Collaborator |
---|---|
Lund University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of BRCA1/2 mutations in an unselected breast cancer cohort in southern Sweden | 3 years | ||
Primary | Uptake of genetic testing | 3 years | ||
Primary | Proportion of the mutation carriers that do not fulfil current criteria for genetic testing | 3 years | ||
Secondary | How many of the patients that contact us for questions | 3 years | ||
Secondary | How uptake of genetic testing varies with the age at diagnosis | Proportion of patients tested in seperate age groups of 10 years. | 3 years | |
Secondary | The patients' attitudes towards the method used for identifying mutation carriers | A questionnaire with 7 general questions (answers graded 1 to 4, where 1 = not at all, and 4 = to a high extent) will be sent the participants one year after the test results were delivered. The questions are in Swedish; translated to English, examples of questions are: "are you content with the method used in the study for informtion?", "would yout have liked to have more oral information?", "are you content with having gone through genetic testing?", "would you recommend a friend of you with breast cancer to pursue genetic testing in the way that you have done?" | 3 years | |
Secondary | Psychosocial comparisons between mutation carriers and non-carriers | Matched comparisons between mutation carriers and non-carriers for psychosocial endpoints will be done in a nested case-control study, where two controls are selected for each mutation carrier on the basis of age, adjuvant chemotherapy, stage and ER status. | 4 years |
Status | Clinical Trial | Phase | |
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Completed |
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