Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
ConditionBreast Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLund University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspicion or confirmed diagnosis of primary breast cancer
signed informed consent
Disqualifiers
lack of signed informed consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Biomarkers and clinicopathological information
Analysis of genomic data (biomarkers) and their relationship to patient and tumor clinicopathological information; assessment of analytical validity.
Time frame
up to 20-years2
Invasive disease-free survival
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.
Time frame
up to 20-yearsSecondary outcomes
1
Overall survival
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.
Time frame
3-years, 5-years, 10-years, 15-years, 20-years2
Breast cancer-specific survival
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.
Time frame
3-years, 5-years, 10-years, 15-years, 20-years3
Pathological response
Different biomarkers will be analysed in the context of pathological response at time of surgery for patients receiving pre-operative therapy.
Time frame
intraoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lund University
Lead sponsor
South Sweden Breast Cancer Group
Collaborator
Mrs. Berta Kamprad Foundation
Collaborator
U-CAN
Collaborator
Source ClinicalTrials.gov