Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
- Conditions
- Breast Neoplasms
- Registration Number
- NCT02306096
- Lead Sponsor
- 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.
- 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 long-sighted 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 February 2024, over 20,000 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.
As of Q4 2021, the SCAN-B RNA-seq analysis for molecular subtyping and risk-of-recurrence has been clinically implemented for all breast cancer patients in Skåne within the Center for Molecular Diagnostics, Laboratory Medicine, Medical Service, Region Skåne.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- suspicion or confirmed diagnosis of primary breast cancer
- signed informed consent
- lack of signed informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biomarkers and clinicopathological information 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 up to 20-years Different biomarkers will be analysed in the context of invasive disease-free survival (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
Name Time Method Breast cancer-specific survival 3-years, 5-years, 10-years, 15-years, 20-years Different biomarkers will be analysed in the context of breast cancer survival (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.
Overall survival 3-years, 5-years, 10-years, 15-years, 20-years Different biomarkers will be analysed in the context of overall survival (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.
Pathological response intraoperative Different biomarkers will be analysed in the context of pathological response at time of surgery for patients receiving pre-operative therapy.
Trial Locations
- Locations (8)
Kirurgiska kliniken
🇸🇪Jönköping, Sweden
Skåne University Hospital
🇸🇪Malmö, Sweden
Central Hospital Växjö
🇸🇪Växjö, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Hallands Hospital Halmstad
🇸🇪Halmstad, Sweden
Helsingborg Hospital
🇸🇪Helsingborg, Sweden
Blekinge County Hospital
🇸🇪Karlskrona, Sweden
Central Hospital Kristianstad
🇸🇪Kristianstad, Sweden