Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
NCT ID: NCT02306096
Last Updated: 2024-02-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
20000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2010-08-31
Study Completion Date
2031-08-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Breast Neoplasms
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* suspicion or confirmed diagnosis of primary breast cancer
* signed informed consent
* signed informed consent
Exclusion Criteria
* lack of signed informed consent
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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South Sweden Breast Cancer Group
UNKNOWN
Sponsor Role
collaborator
Mrs. Berta Kamprad Foundation
UNKNOWN
Sponsor Role
collaborator
U-CAN
UNKNOWN
Sponsor Role
collaborator
Lund University
OTHER
Sponsor Role
lead
Responsible Party
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Åke Borg
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Åke Borg, PhD
Role: STUDY_DIRECTOR
Lund University
Cecilia Hegardt, PhD
Role: STUDY_CHAIR
Lund University
Christer Larsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
Niklas Loman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital
Johan Vallon-Christersson, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
Anna Ehinger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital
Lisa Rydén, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital
Lao H Saal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
Locations
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Hallands Hospital Halmstad
Halmstad, , Sweden
Site Status
SUSPENDED
Helsingborg Hospital
Helsingborg, , Sweden
Site Status
RECRUITING
Kirurgiska kliniken
Jönköping, , Sweden
Site Status
RECRUITING
Blekinge County Hospital
Karlskrona, , Sweden
Site Status
RECRUITING
Central Hospital Kristianstad
Kristianstad, , Sweden
Site Status
RECRUITING
Skåne University Hospital
Lund, , Sweden
Site Status
RECRUITING
Skåne University Hospital
Malmo, , Sweden
Site Status
RECRUITING
Uppsala University Hospital
Uppsala, , Sweden
Site Status
RECRUITING
Central Hospital Växjö
Vaxjo, , Sweden
Site Status
RECRUITING
Countries
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Sweden
Central Contacts
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Facility Contacts
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References
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Ryden L, Loman N, Larsson C, Hegardt C, Vallon-Christersson J, Malmberg M, Lindman H, Ehinger A, Saal LH, Borg A. Minimizing inequality in access to precision medicine in breast cancer by real-time population-based molecular analysis in the SCAN-B initiative. Br J Surg. 2018 Jan;105(2):e158-e168. doi: 10.1002/bjs.10741.
Reference Type
BACKGROUND
Axelsson U, Ryden L, Johnsson P, Eden P, Mansson J, Hallberg IR, Borrebaeck CAK. A multicenter study investigating the molecular fingerprint of psychological resilience in breast cancer patients: study protocol of the SCAN-B resilience study. BMC Cancer. 2018 Aug 6;18(1):789. doi: 10.1186/s12885-018-4669-y.
Reference Type
BACKGROUND
Saal LH, Vallon-Christersson J, Hakkinen J, Hegardt C, Grabau D, Winter C, Brueffer C, Tang MH, Reutersward C, Schulz R, Karlsson A, Ehinger A, Malina J, Manjer J, Malmberg M, Larsson C, Ryden L, Loman N, Borg A. The Sweden Cancerome Analysis Network - Breast (SCAN-B) Initiative: a large-scale multicenter infrastructure towards implementation of breast cancer genomic analyses in the clinical routine. Genome Med. 2015 Feb 2;7(1):20. doi: 10.1186/s13073-015-0131-9. eCollection 2015.
Reference Type
RESULT
Staaf J, Glodzik D, Bosch A, Vallon-Christersson J, Reutersward C, Hakkinen J, Degasperi A, Amarante TD, Saal LH, Hegardt C, Stobart H, Ehinger A, Larsson C, Ryden L, Loman N, Malmberg M, Kvist A, Ehrencrona H, Davies HR, Borg A, Nik-Zainal S. Whole-genome sequencing of triple-negative breast cancers in a population-based clinical study. Nat Med. 2019 Oct;25(10):1526-1533. doi: 10.1038/s41591-019-0582-4. Epub 2019 Sep 30.
Reference Type
RESULT
Vallon-Christersson J, Hakkinen J, Hegardt C, Saal LH, Larsson C, Ehinger A, Lindman H, Olofsson H, Sjoblom T, Warnberg F, Ryden L, Loman N, Malmberg M, Borg A, Staaf J. Cross comparison and prognostic assessment of breast cancer multigene signatures in a large population-based contemporary clinical series. Sci Rep. 2019 Aug 21;9(1):12184. doi: 10.1038/s41598-019-48570-x.
Reference Type
RESULT
Dihge L, Vallon-Christersson J, Hegardt C, Saal LH, Hakkinen J, Larsson C, Ehinger A, Loman N, Malmberg M, Bendahl PO, Borg A, Staaf J, Ryden L. Prediction of Lymph Node Metastasis in Breast Cancer by Gene Expression and Clinicopathological Models: Development and Validation within a Population-Based Cohort. Clin Cancer Res. 2019 Nov 1;25(21):6368-6381. doi: 10.1158/1078-0432.CCR-19-0075. Epub 2019 Jul 24.
Reference Type
RESULT
Lundgren C, Bendahl PO, Borg A, Ehinger A, Hegardt C, Larsson C, Loman N, Malmberg M, Olofsson H, Saal LH, Sjoblom T, Lindman H, Klintman M, Hakkinen J, Vallon-Christersson J, Ferno M, Ryden L, Ekholm M. Agreement between molecular subtyping and surrogate subtype classification: a contemporary population-based study of ER-positive/HER2-negative primary breast cancer. Breast Cancer Res Treat. 2019 Nov;178(2):459-467. doi: 10.1007/s10549-019-05378-7. Epub 2019 Aug 20.
Reference Type
RESULT
Sokilde R, Persson H, Ehinger A, Pirona AC, Ferno M, Hegardt C, Larsson C, Loman N, Malmberg M, Ryden L, Saal L, Borg A, Vallon-Christerson J, Rovira C. Refinement of breast cancer molecular classification by miRNA expression profiles. BMC Genomics. 2019 Jun 17;20(1):503. doi: 10.1186/s12864-019-5887-7.
Reference Type
RESULT
Persson H, Sokilde R, Hakkinen J, Pirona AC, Vallon-Christersson J, Kvist A, Mertens F, Borg A, Mitelman F, Hoglund M, Rovira C. Frequent miRNA-convergent fusion gene events in breast cancer. Nat Commun. 2017 Oct 5;8(1):788. doi: 10.1038/s41467-017-01176-1.
Reference Type
RESULT
Persson H, Sokilde R, Hakkinen J, Vallon-Christersson J, Mitelman F, Borg A, Hoglund M, Rovira C. Analysis of fusion transcripts indicates widespread deregulation of snoRNAs and their host genes in breast cancer. Int J Cancer. 2020 Jun 15;146(12):3343-3353. doi: 10.1002/ijc.32927. Epub 2020 Feb 28.
Reference Type
RESULT
Winter C, Nilsson MP, Olsson E, George AM, Chen Y, Kvist A, Torngren T, Vallon-Christersson J, Hegardt C, Hakkinen J, Jonsson G, Grabau D, Malmberg M, Kristoffersson U, Rehn M, Gruvberger-Saal SK, Larsson C, Borg A, Loman N, Saal LH. Targeted sequencing of BRCA1 and BRCA2 across a large unselected breast cancer cohort suggests that one-third of mutations are somatic. Ann Oncol. 2016 Aug;27(8):1532-8. doi: 10.1093/annonc/mdw209. Epub 2016 May 18.
Reference Type
RESULT
Dahlgren M, George AM, Brueffer C, Gladchuk S, Chen Y, Vallon-Christersson J, Hegardt C, Hakkinen J, Ryden L, Malmberg M, Larsson C, Gruvberger-Saal SK, Ehinger A, Loman N, Borg A, Saal LH. Preexisting Somatic Mutations of Estrogen Receptor Alpha (ESR1) in Early-Stage Primary Breast Cancer. JNCI Cancer Spectr. 2021 Apr 22;5(2):pkab028. doi: 10.1093/jncics/pkab028. eCollection 2021 Apr.
Reference Type
RESULT
Brueffer C, Gladchuk S, Winter C, Vallon-Christersson J, Hegardt C, Hakkinen J, George AM, Chen Y, Ehinger A, Larsson C, Loman N, Malmberg M, Ryden L, Borg A, Saal LH. The mutational landscape of the SCAN-B real-world primary breast cancer transcriptome. EMBO Mol Med. 2020 Oct 7;12(10):e12118. doi: 10.15252/emmm.202012118. Epub 2020 Sep 14.
Reference Type
RESULT
Glodzik D, Bosch A, Hartman J, Aine M, Vallon-Christersson J, Reutersward C, Karlsson A, Mitra S, Nimeus E, Holm K, Hakkinen J, Hegardt C, Saal LH, Larsson C, Malmberg M, Ryden L, Ehinger A, Loman N, Kvist A, Ehrencrona H, Nik-Zainal S, Borg A, Staaf J. Comprehensive molecular comparison of BRCA1 hypermethylated and BRCA1 mutated triple negative breast cancers. Nat Commun. 2020 Jul 27;11(1):3747. doi: 10.1038/s41467-020-17537-2.
Reference Type
RESULT
Larsson C, Ehinger A, Winslow S, Leandersson K, Klintman M, Dahl L, Vallon-Christersson J, Hakkinen J, Hegardt C, Manjer J, Saal L, Ryden L, Malmberg M, Borg A, Loman N. Prognostic implications of the expression levels of different immunoglobulin heavy chain-encoding RNAs in early breast cancer. NPJ Breast Cancer. 2020 Jul 6;6:28. doi: 10.1038/s41523-020-0170-2. eCollection 2020.
Reference Type
RESULT
Fornvik D, Aaltonen KE, Chen Y, George AM, Brueffer C, Rigo R, Loman N, Saal LH, Ryden L. Detection of circulating tumor cells and circulating tumor DNA before and after mammographic breast compression in a cohort of breast cancer patients scheduled for neoadjuvant treatment. Breast Cancer Res Treat. 2019 Sep;177(2):447-455. doi: 10.1007/s10549-019-05326-5. Epub 2019 Jun 24.
Reference Type
RESULT
Brueffer C, Vallon-Christersson J, Grabau D, Ehinger A, Hakkinen J, Hegardt C, Malina J, Chen Y, Bendahl PO, Manjer J, Malmberg M, Larsson C, Loman N, Ryden L, Borg A, Saal LH. Clinical Value of RNA Sequencing-Based Classifiers for Prediction of the Five Conventional Breast Cancer Biomarkers: A Report From the Population-Based Multicenter Sweden Cancerome Analysis Network-Breast Initiative. JCO Precis Oncol. 2018 Mar 9;2:PO.17.00135. doi: 10.1200/PO.17.00135. eCollection 2018.
Reference Type
RESULT
Nilsson MP, Emmertz M, Kristoffersson U, Borg A, Larsson C, Rehn M, Winter C, Saal LH, Brandberg Y, Loman N. Germline mutations in BRCA1 and BRCA2 incidentally revealed in a biobank research study: experiences from re-contacting mutation carriers and relatives. J Community Genet. 2018 Jul;9(3):201-208. doi: 10.1007/s12687-017-0341-5. Epub 2017 Oct 30.
Reference Type
RESULT
Nilsson MP, Winter C, Kristoffersson U, Rehn M, Larsson C, Saal LH, Loman N. Efficacy versus effectiveness of clinical genetic testing criteria for BRCA1 and BRCA2 hereditary mutations in incident breast cancer. Fam Cancer. 2017 Apr;16(2):187-193. doi: 10.1007/s10689-016-9953-x.
Reference Type
RESULT
Demircan K, Bengtsson Y, Sun Q, Brange A, Vallon-Christersson J, Rijntjes E, Malmberg M, Saal LH, Ryden L, Borg A, Manjer J, Schomburg L. Serum selenium, selenoprotein P and glutathione peroxidase 3 as predictors of mortality and recurrence following breast cancer diagnosis: A multicentre cohort study. Redox Biol. 2021 Nov;47:102145. doi: 10.1016/j.redox.2021.102145. Epub 2021 Sep 21.
Reference Type
RESULT
Dalal H, Dahlgren M, Gladchuk S, Brueffer C, Gruvberger-Saal SK, Saal LH. Clinical associations of ESR2 (estrogen receptor beta) expression across thousands of primary breast tumors. Sci Rep. 2022 Mar 18;12(1):4696. doi: 10.1038/s41598-022-08210-3.
Reference Type
RESULT
Demircan K, Sun Q, Bengtsson Y, Seemann P, Vallon-Christersson J, Malmberg M, Saal LH, Ryden L, Minich WB, Borg A, Manjer J, Schomburg L. Autoimmunity to selenoprotein P predicts breast cancer recurrence. Redox Biol. 2022 Jul;53:102346. doi: 10.1016/j.redox.2022.102346. Epub 2022 May 25.
Reference Type
RESULT
Staaf J, Hakkinen J, Hegardt C, Saal LH, Kimbung S, Hedenfalk I, Lien T, Sorlie T, Naume B, Russnes H, Marcone R, Ayyanan A, Brisken C, Malterling RR, Asking B, Olofsson H, Lindman H, Bendahl PO, Ehinger A, Larsson C, Loman N, Ryden L, Malmberg M, Borg A, Vallon-Christersson J. RNA sequencing-based single sample predictors of molecular subtype and risk of recurrence for clinical assessment of early-stage breast cancer. NPJ Breast Cancer. 2022 Aug 16;8(1):94. doi: 10.1038/s41523-022-00465-3.
Reference Type
RESULT
Saghir H, Veerla S, Malmberg M, Ryden L, Ehinger A, Saal LH, Vallon-Christersson J, Borg A, Hegardt C, Larsson C, Haidar A, Hedenfalk I, Loman N, Kimbung S. How Reliable Are Gene Expression-Based and Immunohistochemical Biomarkers Assessed on a Core-Needle Biopsy? A Study of Paired Core-Needle Biopsies and Surgical Specimens in Early Breast Cancer. Cancers (Basel). 2022 Aug 18;14(16):4000. doi: 10.3390/cancers14164000.
Reference Type
RESULT
Bengtsson Y, Demircan K, Vallon-Christersson J, Malmberg M, Saal LH, Ryden L, Borg A, Schomburg L, Sandsveden M, Manjer J. Serum copper, zinc and copper/zinc ratio in relation to survival after breast cancer diagnosis: A prospective multicenter cohort study. Redox Biol. 2023 Jul;63:102728. doi: 10.1016/j.redox.2023.102728. Epub 2023 May 16.
Reference Type
RESULT
Demircan K, Bengtsson Y, Chillon TS, Vallon-Christersson J, Sun Q, Larsson C, Malmberg M, Saal LH, Ryden L, Borg A, Manjer J, Schomburg L. Matched analysis of circulating selenium with the breast cancer selenotranscriptome: a multicentre prospective study. J Transl Med. 2023 Sep 23;21(1):658. doi: 10.1186/s12967-023-04502-y.
Reference Type
RESULT
Sharma A, Weitz P, Wang Y, Liu B, Vallon-Christersson J, Hartman J, Rantalainen M. Development and prognostic validation of a three-level NHG-like deep learning-based model for histological grading of breast cancer. Breast Cancer Res. 2024 Jan 29;26(1):17. doi: 10.1186/s13058-024-01770-4.
Reference Type
RESULT
Sigurjonsdottir G, De Marchi T, Ehinger A, Hartman J, Bosch A, Staaf J, Killander F, Nimeus E. Comparison of SP142 and 22C3 PD-L1 assays in a population-based cohort of triple-negative breast cancer patients in the context of their clinically established scoring algorithms. Breast Cancer Res. 2023 Oct 10;25(1):123. doi: 10.1186/s13058-023-01724-2.
Reference Type
RESULT
Wang Y, Ali MA, Vallon-Christersson J, Humphreys K, Hartman J, Rantalainen M. Transcriptional intra-tumour heterogeneity predicted by deep learning in routine breast histopathology slides provides independent prognostic information. Eur J Cancer. 2023 Sep;191:112953. doi: 10.1016/j.ejca.2023.112953. Epub 2023 Jun 23.
Reference Type
RESULT
Nacer DF, Vallon-Christersson J, Nordborg N, Ehrencrona H, Kvist A, Borg A, Staaf J. Molecular characteristics of breast tumors in patients screened for germline predisposition from a population-based observational study. Genome Med. 2023 Apr 14;15(1):25. doi: 10.1186/s13073-023-01177-4.
Reference Type
RESULT
Gulis K, Ellbrant J, Svensjo T, Skarping I, Vallon-Christersson J, Loman N, Bendahl PO, Ryden L. A prospective cohort study identifying radiologic and tumor related factors of importance for breast conserving surgery after neoadjuvant chemotherapy. Eur J Surg Oncol. 2023 Jul;49(7):1189-1195. doi: 10.1016/j.ejso.2023.03.225. Epub 2023 Mar 28.
Reference Type
RESULT
Bjorklund SS, Aure MR, Hakkinen J, Vallon-Christersson J, Kumar S, Evensen KB, Fleischer T, Tost J; OSBREAC; Sahlberg KK, Mathelier A, Bhanot G, Ganesan S, Tekpli X, Kristensen VN. Subtype and cell type specific expression of lncRNAs provide insight into breast cancer. Commun Biol. 2022 Aug 18;5(1):834. doi: 10.1038/s42003-022-03559-7.
Reference Type
RESULT
Sartor H, Zackrisson S, Hegardt C, Larsson C. "Association of mammographic features with molecular breast tumor profiles". Cancer Treat Res Commun. 2021;28:100387. doi: 10.1016/j.ctarc.2021.100387. Epub 2021 May 9.
Reference Type
RESULT
Veerla S, Hohmann L, Nacer DF, Vallon-Christersson J, Staaf J. Perturbation and stability of PAM50 subtyping in population-based primary invasive breast cancer. NPJ Breast Cancer. 2023 Oct 19;9(1):83. doi: 10.1038/s41523-023-00589-0.
Reference Type
RESULT
Aine M, Boyaci C, Hartman J, Hakkinen J, Mitra S, Campos AB, Nimeus E, Ehinger A, Vallon-Christersson J, Borg A, Staaf J. Molecular analyses of triple-negative breast cancer in the young and elderly. Breast Cancer Res. 2021 Feb 10;23(1):20. doi: 10.1186/s13058-021-01392-0.
Reference Type
RESULT
Sigurjonsdottir G, De Marchi T, Ehinger A, Hartman J, Ullen S, Leandersson K, Bosch A, Staaf J, Killander F, Nimeus E. Evaluation of alternative prognostic thresholds for SP142 and 22C3 immunohistochemical PD-L1 expression in triple-negative breast cancer: results from a population-based cohort. Breast Cancer Res Treat. 2025 Apr;210(2):271-284. doi: 10.1007/s10549-024-07561-x. Epub 2024 Dec 10.
Reference Type
DERIVED
Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothe F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nat Commun. 2024 Nov 29;15(1):10402. doi: 10.1038/s41467-024-54621-3.
Reference Type
DERIVED
Fornvik D, Borgquist S, Larsson M, Zackrisson S, Skarping I. Deep learning analysis of serial digital breast tomosynthesis images in a prospective cohort of breast cancer patients who received neoadjuvant chemotherapy. Eur J Radiol. 2024 Sep;178:111624. doi: 10.1016/j.ejrad.2024.111624. Epub 2024 Jul 14.
Reference Type
DERIVED
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: RNA-seq Processed Gene Expression Data and Annotations (n=49 patients)
SuperSeries: GSE60789 SubSeries: GSE60785, GSE60788
View DocumentDocument Type: RNA-seq Processed Gene Expression Data and Annotations (n=3678 patients)
SuperSeries: GSE81540 SubSeries: GSE81538, GSE96058
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
https://www.scan-b.lu.se
Sweden Cancerome Analysis Network - Breast (SCAN-B) Website (Lund University) \[SWEDISH LANGUAGE\]
Other Identifiers
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SCANB001
Identifier Type: -
Identifier Source: org_study_id
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