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

Sponsor
Lund University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02306096
Collaborator
South Sweden Breast Cancer Group (Other), Mrs. Berta Kamprad Foundation (Other), U-CAN (Other)
20,000
9
252
2222.2
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 October 2021, over 17,000 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    SCAN-B: The Sweden Cancerome Analysis Network - Breast Initiative
    Study Start Date :
    Aug 1, 2010
    Anticipated Primary Completion Date :
    Aug 1, 2031
    Anticipated Study Completion Date :
    Aug 1, 2031

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Invasive disease-free survival [up to 20-years]

      Different biomarkers will be analysed in the context of 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

    1. Overall survival [3-years, 5-years, 10-years, 15-years, 20-years]

      Different biomarkers will be analysed in the context of 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.

    2. Breast cancer-specific survival [3-years, 5-years, 10-years, 15-years, 20-years]

      Different biomarkers will be analysed in the context of 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. Pathological response [intraoperative]

      Different biomarkers will be analysed in the context of pathological response at time of surgery for patients receiving pre-operative therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • suspicion or confirmed diagnosis of primary breast cancer

    • signed informed consent

    Exclusion Criteria:
    • lack of signed informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hallands Hospital Halmstad Halmstad Sweden 30233
    2 Helsingborg Hospital Helsingborg Sweden 25187
    3 Kirurgiska kliniken Jönköping Sweden 55185
    4 Blekinge County Hospital Karlskrona Sweden 37185
    5 Central Hospital Kristianstad Kristianstad Sweden 29185
    6 Skåne University Hospital Lund Sweden 22185
    7 Skåne University Hospital Malmö Sweden 20502
    8 Uppsala University Hospital Uppsala Sweden 75185
    9 Central Hospital Växjö Växjö Sweden 35234

    Sponsors and Collaborators

    • Lund University
    • South Sweden Breast Cancer Group
    • Mrs. Berta Kamprad Foundation
    • U-CAN

    Investigators

    • Study Director: Åke Borg, PhD, Lund University
    • Principal Investigator: Cecilia Hegardt, PhD, Lund University
    • Principal Investigator: Christer Larsson, PhD, Lund University
    • Principal Investigator: Niklas Loman, MD, PhD, Skane University Hospital
    • Study Chair: Martin Malmberg, 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 Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Åke Borg, Professor, Lund University
    ClinicalTrials.gov Identifier:
    NCT02306096
    Other Study ID Numbers:
    • SCANB001
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Sep 1, 2021

    Study Results

    No Results Posted as of Sep 10, 2021