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Recruiting NCT02306096

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

— Observational Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Neoplasms. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Biomarkers and clinicopathological information [Time frame: up to 20-years]
  • Invasive disease-free survival [Time frame: up to 20-years]
Secondary outcome measures (3)
  • Overall survival [Time frame: 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]
  • Pathological response [Time frame: intraoperative]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • lack of signed informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 9 centers
  • Hallands Hospital Halmstad — Halmstad
  • Helsingborg Hospital — Helsingborg
  • Kirurgiska kliniken — Jönköping
  • Blekinge County Hospital — Karlskrona
  • Central Hospital Kristianstad — Kristianstad
  • Skåne University Hospital — Lund
  • Skåne University Hospital — Malmö
  • Uppsala University Hospital — Uppsala
  • … and 1 more center

Publications

  • 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. PMID 29341157
  • 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. PMID 30081937
  • 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 routi PMID 25722745
  • 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- PMID 31570822
  • 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. PMID 31434940
  • 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 201 PMID 31340938
  • 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 PMID 31432367
  • 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. PMID 31208318

Identifiers

NCT: NCT02306096 · SCANB001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗