OPTIMA: Optimising Mammography Assesment Via Blood-based Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Correlation between blood samples and clinical mammography result
研究概览
简要总结
The project aims to investigate whether breast cancer screening can be improved using blood tests, thereby reducing the number of unnecessary clinical mammographies. The Danish breast cancer screening program was implemented in 2007, and currently, all women aged 50-69 are invited every two years to participate. Those who have a suspecious screening mammography are referred to a clinical mammography where further assesment with more mammographies, ultra-sound and possibly biopsies are conducted. Around 75% of the women that are referred to further assesment can be classified as unnecessary, as no breastcancer is found. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources.
The project seeks to reduce the number of these unnecessary clinical mammographies by investigating whether blood biomarkers can identify women at very low risk of breast cancer after a positive mammography screening. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.
详细描述
The study aims to determine if minor irregularities in blood-based biomarkers can identify women with a very low breast cancer risk. Blood samples will be collected from 1200 women attending clinical mammography/recall after a positive mammography screening. Routine blood analyses will be conducted immediately, while blood for special analyses will be stored at -80 °C until analysis.
The study can be divided into sub-studies:
One that will solely focus on the routine blood analyses and evaluate their potential.
And one that will include the analysis of biomarkers that is not yet incorporated into the routine sample track at Vejle or Odense Hospital to see if the inclusion of special biomarkers can improve the breast cancer risk prediction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participation in the Danish breast cancer screening program
排除标准
- •No clinical mammography conducted
研究组 & 干预措施
Mammography screening positive women
All citizens referred to a clinical mammography at Vejle Hospital or Odense University Hospital in the breast cancer screening program are offered to participate in the study. If the participant agrees, they will have blood drawn and sign a declaration of consent.
Statistically, approximately 25 % will be diagnosed with breastcancer
结局指标
主要结局
Correlation between blood samples and clinical mammography result
时间窗: 6 weeks from clinical mammography date
The aim is to investigate the womens chance of being healthy despite a positive tmammography screening. The chance of being healthy is estimated from the combined blood sample results and will be compared to the results of the clinical mammography.
次要结局
- Correlation between blood samples and interval breast cancer(From 6 weeks after the clinical mammography to next mammographyscreening, up to 3 years)