Clinical trial NCT02306096: Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
Official title: SCAN-B: The Sweden Cancerome Analysis Network - Breast Initiative
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Keywords: prognostic and predictive biomarkers
RNA-sequencing
pathological complete response
minimal residual disease
molecular subtype
gene expression profiling
mutation screening
BRCA
translational research
genomics
transcriptomics
proteomics
metabolomics
liquid biopsy
circulating tumor cells
circulating tumor DNA
RNA-seq
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: South Sweden Breast Cancer Group
name: Mrs. Berta Kamprad Foundation
name: U-CAN
First posted: 2014-12-03
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* lack of signed informed consent

Primary outcomes:
measure: Biomarkers and clinicopathological information
timeFrame: up to 20-years
measure: Invasive disease-free survival
timeFrame: up to 20-years
Secondary outcomes:
measure: Overall survival
timeFrame: 3-years, 5-years, 10-years, 15-years, 20-years
measure: Breast cancer-specific survival
timeFrame: 3-years, 5-years, 10-years, 15-years, 20-years
measure: Pathological response
timeFrame: intraoperative
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Jönköping
country: Sweden
facility: Kirurgiska kliniken
city: Karlskrona
country: Sweden
facility: Blekinge County Hospital
city: Kristianstad
country: Sweden
facility: Central Hospital Kristianstad
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Växjö
country: Sweden
facility: Central Hospital Växjö
Study officials:
affiliation: Lund University
name: Åke Borg, PhD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Cecilia Hegardt, PhD
role: STUDY_CHAIR
affiliation: Lund University
name: Christer Larsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Niklas Loman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Johan Vallon-Christersson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Anna Ehinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Lisa Rydén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Lao H Saal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
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citation: 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.
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