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
|Condition or disease|
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|
|Estimated Enrollment :||20000 participants|
|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|
- 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.
- 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.
Biospecimen Retention: Samples With DNA
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
|Contact: Åke Borg, PhDfirstname.lastname@example.org|
|Contact: Martin Malmberg, MD, PhDemail@example.com|
|Hallands Hospital Halmstad||Recruiting|
|Halmstad, Sweden, 30233|
|Contact: Lars Åhlund, MD firstname.lastname@example.org|
|Helsingborg, Sweden, 25187|
|Contact: Anna-Karin Falck, MD email@example.com|
|Jönköping, Sweden, 55185|
|Contact: Bengt Asking, MD +46-36-321353 firstname.lastname@example.org|
|Blekinge County Hospital||Recruiting|
|Karlskrona, Sweden, 37185|
|Contact: Monika Sjövall, MD email@example.com|
|Central Hospital Kristianstad||Recruiting|
|Kristianstad, Sweden, 29185|
|Contact: Tor Svensjö, MD, PhD firstname.lastname@example.org|
|Skåne University Hospital||Recruiting|
|Lund, Sweden, 22185|
|Contact: Lisa Rydén, MD PhD +46-46-176241 email@example.com|
|Skåne University Hospital||Recruiting|
|Malmö, Sweden, 20502|
|Contact: Martin Rehn, MD, PhD +46-40-331892 firstname.lastname@example.org|
|Uppsala University Hospital||Recruiting|
|Uppsala, Sweden, 75185|
|Contact: Tobias Sjöblom, PhD +46-18-4715036 email@example.com|
|Central Hospital Växjö||Recruiting|
|Växjö, Sweden, 35234|
|Contact: Per Weber, MD +46-470-588052 firstname.lastname@example.org|
|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|