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

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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

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.

Condition or disease
Breast Neoplasms

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.


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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCAN-B: The Sweden Cancerome Analysis Network - Breast Initiative
Study Start Date : August 2010
Estimated Primary Completion Date : August 2031
Estimated Study Completion Date : August 2031

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Tumor tissue, whole blood, serum, plasma. Collected at diagnosis and during follow-up.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • lack of signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306096


Contacts
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Contact: Åke Borg, PhD +46-46-2752552 ake.borg@med.lu.se
Contact: Martin Malmberg, MD, PhD martin.malmberg@skane.se

Locations
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Sweden
Hallands Hospital Halmstad Recruiting
Halmstad, Sweden, 30233
Contact: Lars Åhlund, MD       lars.ahlund@regionhalland.se   
Helsingborg Hospital Recruiting
Helsingborg, Sweden, 25187
Contact: Anna-Karin Falck, MD       anna-karin.falck@skane.se   
Kirurgiska kliniken Recruiting
Jönköping, Sweden, 55185
Contact: Bengt Asking, MD    +46-36-321353    bengt.asking@rjl.se   
Blekinge County Hospital Recruiting
Karlskrona, Sweden, 37185
Contact: Monika Sjövall, MD       monika.sjovall@ltblekinge.se   
Central Hospital Kristianstad Recruiting
Kristianstad, Sweden, 29185
Contact: Tor Svensjö, MD, PhD       tor.svensjo@skane.se   
Skåne University Hospital Recruiting
Lund, Sweden, 22185
Contact: Lisa Rydén, MD PhD    +46-46-176241    lisa.ryden@med.lu.se   
Skåne University Hospital Recruiting
Malmö, Sweden, 20502
Contact: Martin Rehn, MD, PhD    +46-40-331892    martin.rehn@skane.se   
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Tobias Sjöblom, PhD    +46-18-4715036    tobias.sjoblom@igp.uu.se   
Central Hospital Växjö Recruiting
Växjö, Sweden, 35234
Contact: Per Weber, MD    +46-470-588052    per.weber@ltkronoberg.se   
Sponsors and Collaborators
Lund University
South Sweden Breast Cancer Group
Mrs. Berta Kamprad Foundation
U-CAN
Investigators
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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

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Åke Borg, Professor, Lund University
ClinicalTrials.gov Identifier: NCT02306096     History of Changes
Other Study ID Numbers: SCANB001
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon publication, the relevant anonymized individual participant data will be shared.

Keywords provided by Åke Borg, Lund University:
prognostic and predictive biomarkers
RNA-sequencing
pathological complete response
minimal residual disease
molecular subtype
gene expression profiling
mutation screening
BRCA
translational research
genomics
transcriptomics
proteomics
metabolomics
liquid biopsy
circulating tumor cells
circulating tumor DNA

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases