Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer (SCAN-B)

August 24, 2026 updated by: Åke Borg, Lund University

SCAN-B: The Sweden Cancerome Analysis Network - Breast Initiative

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Borås, Sweden
      • Halmstad, Sweden, 30233
        • Suspended
        • Hallands Hospital Halmstad
      • Helsingborg, Sweden, 25187
      • Jönköping, Sweden, 55185
        • Suspended
        • Kirurgiska kliniken
      • Karlskrona, Sweden, 37185
      • Kristianstad, Sweden, 29185
        • Recruiting
        • Central Hospital Kristianstad
        • Contact:
      • Lund, Sweden, 22185
        • Recruiting
        • Skane University Hospital
        • Contact:
      • Malmö, Sweden, 20502
        • Recruiting
        • Skane University Hospital
        • Contact:
      • Uppsala, Sweden, 75185
        • Recruiting
        • Uppsala University Hospital
        • Contact:
      • Vaxjo, Sweden, 35234
        • Recruiting
        • Central Hospital Växjö
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria:

  • suspicion or confirmed diagnosis of primary breast cancer
  • signed informed consent

Exclusion Criteria:

  • lack of signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 20-years
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.
up to 20-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative
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.
3-years, 5-years, 10-years, 15-years, 20-years
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.
3-years, 5-years, 10-years, 15-years, 20-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Åke Borg, PhD, Lund University
  • Principal Investigator: Christer Larsson, PhD, Lund University
  • Principal Investigator: Niklas Loman, MD, PhD, Skane University Hospital
  • 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 Chair: Cecilia Hegardt, PhD, Lund University
  • Principal Investigator: Johan Vallon-Christersson, PhD, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimated)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon publication, the relevant anonymized individual participant data will be shared.

Study Data/Documents

  1. RNA-seq Processed Gene Expression Data and Annotations (n=49 patients)
    Information identifier: GSE60789
    Information comments: SuperSeries: GSE60789 SubSeries: GSE60785, GSE60788
  2. RNA-seq Processed Gene Expression Data and Annotations (n=3678 patients)
    Information identifier: GSE81540
    Information comments: SuperSeries: GSE81540 SubSeries: GSE81538, GSE96058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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