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NCT Number: NCT02306096

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

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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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasm, Residual Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallands Hospital Halmstad, Halmstad, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • lack of signed informed consent

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lao Saal, MD, PhD

CONTACT

[email protected]

Åke Borg, PhD

CONTACT

[email protected]

+46-46-2752552

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SCAN-B

Important dates

Study start
2010
Primary completion
2031
Study completion
2031
First posted
Dec 3, 2014
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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