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 : February 9, 2024
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Condition or disease |
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Breast Neoplasms |
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.
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 |
- 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 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.
- Overall survival [ Time Frame: 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.
- 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 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.
- 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
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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 |
Inclusion Criteria:
- suspicion or confirmed diagnosis of primary breast cancer
- signed informed consent
Exclusion Criteria:
- lack of signed informed consent
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, PhD | +46-46-2752552 | ake.borg@med.lu.se | |
Contact: Lao Saal, MD, PhD | lao.saal@med.lu.se |
Sweden | |
Hallands Hospital Halmstad | Suspended |
Halmstad, Sweden, 30233 | |
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 |
Study Director: | Åke Borg, PhD | Lund University | |
Study Chair: | Cecilia Hegardt, PhD | Lund University | |
Principal Investigator: | Christer Larsson, PhD | Lund University | |
Principal Investigator: | Niklas Loman, MD, PhD | Skane University Hospital | |
Principal Investigator: | Johan Vallon-Christersson, PhD | Lund University | |
Principal Investigator: | Anna Ehinger, MD, PhD | Skane University Hospital | |
Principal Investigator: | Lisa Rydén, MD, PhD | Skane University Hospital | |
Principal Investigator: | Lao H Saal, MD, PhD | Lund University |
Study Data/Documents: RNA-seq Processed Gene Expression Data and Annotations (n=49 patients)
SuperSeries: GSE60789 SubSeries: GSE60785, GSE60788
SuperSeries: GSE81540 SubSeries: GSE81538, GSE96058
Publications of Results:
Other Publications:
Responsible Party: | Åke Borg, Professor, Lund University |
ClinicalTrials.gov Identifier: | NCT02306096 |
Other Study ID Numbers: |
SCANB001 |
First Posted: | December 3, 2014 Key Record Dates |
Last Update Posted: | February 9, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Upon publication, the relevant anonymized individual participant data will be shared. |
genomics circulating tumor DNA prognostic and predictive biomarkers RNA-sequencing pathological complete response minimal residual disease molecular subtype gene expression profiling mutation screening |
BRCA translational research transcriptomics proteomics metabolomics liquid biopsy circulating tumor cells RNA-seq |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |