Optimising Mammography Screening Accuracy With Blood-based Biomarkers
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 Cancer. Basic parameters: 50 years — 69 years · Female.
- 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
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
OPTIMA: Optimising Mammography Assesment Via Blood-based Biomarkers
Overview
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.
Detailed description
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.
Primary outcome measures
- Correlation between blood samples and clinical mammography result [Time frame: 6 weeks from clinical mammography date]
Secondary outcome measures (1)
- Correlation between blood samples and interval breast cancer [Time frame: From 6 weeks after the clinical mammography to next mammographyscreening, up to 3 years]
Eligibility criteria
Inclusion criteria
- Participation in the Danish breast cancer screening program
Exclusion criteria
- No clinical mammography conducted
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
Denmark · 2 centers
- Odense University Hospital — Odense
- Vejle Hospital — Vejle
Identifiers
NCT: NCT07049822 · 24/54432 - OPTIMA