Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02557776
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2015-06-03
Brief Title:
Written Genetic Counseling and Mutation Analysis of BRCA1 and BRCA2 to Patients With Breast Cancer
Sponsor:
Lund University
Organization:
Lund University
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRCAsearch
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None