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National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations (MR BRCA)

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ClinicalTrials.gov Identifier: NCT00413491
Recruitment Status : Unknown
Verified January 2009 by Danish Breast Cancer Cooperative Group.
Recruitment status was:  Recruiting
First Posted : December 19, 2006
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Danish Breast Cancer Cooperative Group

Tracking Information
First Submitted Date  ICMJE December 14, 2006
First Posted Date  ICMJE December 19, 2006
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2006)
Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.
Change History Complete list of historical versions of study NCT00413491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
  • Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue. [ Time Frame: 3 years ]
  • Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2006)
  • Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.
  • Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations
Official Title  ICMJE National Screening i Danmark Med MR-scanning af Brystet Kontra Klinisk Mammografi Hos Kvinder Der er bærere af Risikogivende BRCA1 Eller BRCA2 Mutationer
Brief Summary The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.
Detailed Description

Study type : Interventional Study design: Diagnostic,Prospective,Non Randomised,Blinded,Efficacy study

Further study details as provided by DBCG ( Danish Breast Cancer Cooperative Group):

Primary outcome measures:

Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.

Secondary outcome measures:

Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.

Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.

Study start : January 2007. Expected completion 2010.

Women with BRCA gene mutations are more likely than others to develop the disease at a young age when breast density is higher than at older age.The tumours often are more rapidly developing with a short presymptomatic phase. These factors are known to reduce the effectiveness of screening with mammography and mammography seems to have a low sensitivity in women with BRCA gene mutations. Other studies have shown that more than 50% of the cancers appears as interval cancers between two mammography screening examinations and many have positive axillary nodes at the time of diagnosis.

Around 610 women are tested BRCA gene positive in Denmark in year 2006. These women are offered a yearly screening with mammography combined with ultrasound and a clinical examination. The trial will test whether this screening offer should be combined with or replaced by MR mammography.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: MR mammography
    MR mammography
  • Procedure: MR
    MR
Study Arms Experimental: 1
Comparison of MR and mammography
Interventions:
  • Procedure: MR mammography
  • Procedure: MR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 18, 2006)
300
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women tested positive of BRCA1 or BRCA2 gene mutations
  • referred for screening
  • aged 25 - 70 years

Exclusion Criteria:

  • general contraindications for MR
  • pregnant or lactating
  • men
  • bilateral mastectomy
  • ongoing treatment with chemotherapy
  • metastatic breast cancer
  • previous breast surgery less than 6 months before MR
  • previous radiation therapy of the breast less than 1 year before
  • incapable of managing her own affairs
Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00413491
Other Study ID Numbers  ICMJE DBCG07MRBRCA
DBCG07MRBRCA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Danish Breast Cancer Cooperative Group
Study Sponsor  ICMJE Danish Breast Cancer Cooperative Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ilse Vejborg, MD Danish Breast Cancer Cooperative Group
PRS Account Danish Breast Cancer Cooperative Group
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP