跳至主要内容
临床试验/NCT02306096
NCT02306096招募中不适用

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

Lund University18 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20,000
试验地点
18
主要终点
Biomarkers and clinicopathological information

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • lack of signed informed consent

结局指标

主要结局

Biomarkers and clinicopathological information

时间窗: up to 20-years

Analysis of genomic data (biomarkers) and their relationship to patient and tumor clinicopathological information; assessment of analytical validity.

Invasive disease-free survival

时间窗: 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.

次要结局

  • Breast cancer-specific survival(3-years, 5-years, 10-years, 15-years, 20-years)
  • Overall survival(3-years, 5-years, 10-years, 15-years, 20-years)
  • Pathological response(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Åke Borg

Professor

Lund University

研究点 (18)

Loading locations...

相似试验

Sweden Cancerome Analysis Network - Breast : Genomic... | 临床试验