Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Study population:
All patients with newly diagnosed breast cancer in southern Sweden are offered inclusion in the SCAN-B study at the time of diagnosis pre-surgery. If they consent to that, a part of the tumor is sent to a lab in Lund, Sweden, for research purposes (RNA sequencing etc.). Patients that are included in the SCAN-B study are eligible for inclusion in BRCAsearch, see inclusion and exclusion criteria.
Study procedure (summary):
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetic testing of BRCA1 and BRCA2 | Experimental | For detailes, please see "Study procedure". Women with newely diagnosed breast cancer are offered written genetic counseling and screening of mutations in BRCA1 and BRCA2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Germline genetic testing of BRCA1 and BRCA2 | Genetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of BRCA1/2 mutations in an unselected breast cancer cohort in southern Sweden | 3 years | |
| Uptake of genetic testing | 3 years | |
| Proportion of the mutation carriers that do not fulfil current criteria for genetic testing | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| How many of the patients that contact us for questions | 3 years | |
| How uptake of genetic testing varies with the age at diagnosis | Proportion of patients tested in seperate age groups of 10 years. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niklas Loman, MD, PhD | Head of Section for Breast Cancer, Melanoma and CNS tumors. Dept of Oncology, Skane University Hospital, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsingborg Hospital, Dept of Surgergy | Helsingborg | Sweden | ||||
| Kristianstad Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29164420 | Derived | Nilsson MP, Torngren T, Henriksson K, Kristoffersson U, Kvist A, Silfverberg B, Borg A, Loman N. BRCAsearch: written pre-test information and BRCA1/2 germline mutation testing in unselected patients with newly diagnosed breast cancer. Breast Cancer Res Treat. 2018 Feb;168(1):117-126. doi: 10.1007/s10549-017-4584-y. Epub 2017 Nov 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C562840 | Breast Cancer, Familial |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years |
| 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 |
| 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 |
| Kristianstad |
| Sweden |