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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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):

1. An envelope with written information is given to the patient at the visit to the surgeon the week after surgery. This envelope contains a written genetic counseling, information about the study, an informed consent form, psychosocial questionnaires and our contact information (telephone, e-mail). The patient can contact a genetic counselor for pre-test telephone genetic counseling if she wishes to.

2. BRCA1 and BRCA2 are analyzed by full sequencing.

3. Non-carriers are informed about the test result with a letter. Mutation carriers and VUS (variants of uncertain significance) are telephoned and given a time for an appointment at the Department of Clinical Genetics within a week.

4. Psychosocial self-reported questionnaires (HAD scale, EORTC QLQ-C30, EORTC QLQ-BR23) are delivered at 3 times: At invitation to the study, one month after information about test result, and one year after information about test result.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Germline genetic testing of BRCA1 and BRCA2


Locations

Country Name City State
Sweden Helsingborg Hospital, Dept of Surgergy Helsingborg
Sweden Kristianstad Central Hospital Kristianstad

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

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
See also
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Completed NCT03959267 - Testing a Culturally Adapted Telephone Genetic Counseling Intervention N/A
Recruiting NCT03495544 - Study Estimating Association Between Germline Mutations and PD-L1 Expression in Breast Cancer
Enrolling by invitation NCT04197856 - Direct Information to At-risk Relatives N/A