Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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 November 2014, over 6000 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- suspicion or confirmed diagnosis of primary breast cancer

- signed informed consent

Exclusion Criteria:

- lack of signed informed consent
Locations
Hallands Hospital Halmstad
Halmstad, Sweden
Status: Recruiting
Contact: Lars Åhlund, MD - lars.ahlund@regionhalland.se
Helsingborg Hospital
Helsingborg, Sweden
Status: Recruiting
Contact: Anna-Karin Falck, MD - anna-karin.falck@skane.se
Blekinge County Hospital
Karlskrona, Sweden
Status: Recruiting
Contact: Monika Sjövall, MD - monika.sjovall@ltblekinge.se
Central Hospital Kristianstad
Kristianstad, Sweden
Status: Recruiting
Contact: Heitti Teder, MD - heitti.teder@skane.se
Skåne University Hospital
Lund, Sweden
Status: Recruiting
Contact: Lisa Rydén, MD PhD - +46-46-176241 - lisa.ryden@med.lu.se
Skåne University Hospital
Malmö, Sweden
Status: Recruiting
Contact: Martin Rehn, MD, PhD - +46-40-331892 - martin.rehn@skane.se
Uppsala University Hospital
Uppsala, Sweden
Status: Recruiting
Contact: Tobias Sjöblom, PhD - +46-18-4715036 - tobias.sjoblom@igp.uu.se
Central Hospital Växjö
Växjö, Sweden
Status: Recruiting
Contact: Per Weber, MD - +46-470-588052 - per.weber@ltkronoberg.se
Start Date
August 2010
Completion Date
August 2031
Sponsors
Lund University
Source
Lund University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page