Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer (SCAN-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306096
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
South Sweden Breast Cancer Group
Mrs. Berta Kamprad Foundation
U-CAN
Information provided by (Responsible Party):
Åke Borg, Lund University

Tracking Information
First Submitted Date December 1, 2014
First Posted Date December 3, 2014
Last Update Posted Date January 23, 2019
Study Start Date August 2010
Estimated Primary Completion Date August 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2014)
  • Biomarkers and clinicopathological information [ Time Frame: up to 20-years ]
    Analysis of genomic data (biomarkers) and their relationship to patient and tumor clinicopathological information; assessment of analytical validity.
  • Invasive disease-free survival [ Time Frame: up to 20-years ]
    Different biomarkers will be analysed in the context of IDFS at different time-points for different subgroups of the prospective cohort, for example for all patients receiving a particular therapy or patients with tumors of a specific molecular subtype.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 2, 2014)
  • Overall survival [ Time Frame: 3-years, 5-years, 10-years, 15-years, 20-years ]
    Different biomarkers will be analysed in the context of OS at different time-points for different subgroups of the prospective cohort, for example for all patients receiving a particular therapy or patients with tumors of a specific molecular subtype.
  • Breast cancer-specific survival [ Time Frame: 3-years, 5-years, 10-years, 15-years, 20-years ]
    Different biomarkers will be analysed in the context of BCS at different time-points for different subgroups of the prospective cohort, for example for all patients receiving a particular therapy or patients with tumors of a specific molecular subtype.
  • Pathological response [ Time Frame: intraoperative ]
    Different biomarkers will be analysed in the context of pathological response at time of surgery for patients receiving pre-operative therapy.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
Official Title SCAN-B: The Sweden Cancerome Analysis Network - Breast Initiative
Brief Summary This study evaluates the genomic profiles of breast cancer in a prospective and population-based manner. In the first phase, breast tumors are analyzed by whole transcriptome RNA-sequencing. Gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses will be performed in the future.
Detailed Description

Breast cancer exhibits significant molecular, pathological, and clinical heterogeneity. Current patient and clinicopathological evaluation is imperfect for predicting outcome, which results in overtreatment for many patients, and for others, leads to death from recurrent disease. Therefore, additional criteria are needed to better personalize care and maximize treatment effectiveness and survival.

The Sweden Cancerome Analysis Network - Breast (SCAN-B) study was initiated in 2010 as a multicenter prospective population-based observational study with longsighted aims to analyze breast cancers with next-generation genomic technologies for translational research and integrated with healthcare; decipher fundamental tumor biology from these analyses; utilize genomic data to develop and validate new clinically-actionable biomarker assays; and establish real-time clinical implementation of molecular diagnostic, prognostic, and predictive tests. In the first phase, we focus on molecular profiling by next-generation RNA-sequencing. Gene expression profiles, mutational profiles, and transcript isoform-level data will be analyzed in the context of patient information, clinicopathological variables, and outcome, with the purpose to develop new molecular diagnostic assays for breast cancer. Additional genome-scale RNA, DNA, and protein analyses will be performed in the future.

As of January 2019, nearly 13,000 patients have enrolled in the study, representing approximately 85% of all eligible patients within the catchment region. Tissue and blood collection is integrated within healthcare routines and clinical information is provided from national quality registries.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue, whole blood, serum, plasma. Collected at diagnosis and during follow-up.
Sampling Method Probability Sample
Study Population All patients with suspected or confirmed diagnosis of primary breast cancer within participating hospital systems in the South Sweden Healthcare Region, Uppsala County, and Jönköping Country, Sweden. Additional hospital sites from within the Nordic countries are welcome to join.
Condition Breast Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2019)
20000
Original Estimated Enrollment
 (submitted: December 2, 2014)
10000
Estimated Study Completion Date August 2031
Estimated Primary Completion Date August 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • suspicion or confirmed diagnosis of primary breast cancer
  • signed informed consent

Exclusion Criteria:

  • lack of signed informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Åke Borg, PhD +46-46-2752552 ake.borg@med.lu.se
Contact: Martin Malmberg, MD, PhD martin.malmberg@skane.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02306096
Other Study ID Numbers SCANB001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Upon publication, the relevant anonymized individual participant data will be shared.
Responsible Party Åke Borg, Lund University
Study Sponsor Lund University
Collaborators
  • South Sweden Breast Cancer Group
  • Mrs. Berta Kamprad Foundation
  • U-CAN
Investigators
Study Director: Åke Borg, PhD Lund University
Principal Investigator: Cecilia Hegardt, PhD Lund University
Principal Investigator: Christer Larsson, PhD Lund University
Principal Investigator: Niklas Loman, MD, PhD Skane University Hospital
Study Chair: Martin Malmberg, MD, PhD Skane University Hospital
Principal Investigator: Anna Ehinger, MD Skane University Hospital
Principal Investigator: Lisa Rydén, MD, PhD Skane University Hospital
Principal Investigator: Lao H Saal, MD, PhD Lund University
PRS Account Lund University
Verification Date January 2019