Written Genetic Counseling and Mutation Analysis of BRCA1 and BRCA2 to Patients With Breast Cancer

NCT02557776 | Completed

• 1 other identifier: Dnr 2009/659
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hereditary Breast Cancer

Keywords

BRCA1; BRCA2; hereditary breast cancer; genetic counseling

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• How many of the patients that contact us for questions

  3 years

• How uptake of genetic testing varies with the age at diagnosis

  3 years

• The patients' attitudes towards the method used for identifying mutation carriers

  3 years

• Psychosocial comparisons between mutation carriers and non-carriers

  4 years

Study Arms (1)

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.

Genetic: Germline genetic testing of BRCA1 and BRCA2

Interventions

Germline genetic testing of BRCA1 and BRCA2 GENETIC

Genetic testing of BRCA1 and BRCA2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is included in the SCAN-B study.
• The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ.
• The patient has signed an informed consent form.

You may not qualify if:

• The patient is unable to understand the written information in Swedish.
• 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.

Sponsors & Collaborators

• Lund University: lead

Study Sites (2)

Helsingborg Hospital, Dept of Surgergy

Helsingborg, Sweden

Location

Kristianstad Central Hospital

Kristianstad, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29164420 DERIVED

MeSH Terms

Conditions

Breast Cancer, Familial

Study Officials

• Niklas Loman, MD, PhD

  Head of Section for Breast Cancer, Melanoma and CNS tumors. Dept of Oncology, Skane University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: September 23, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)