Optimising Mammography Screening Accuracy With Blood-based Biomarkers

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–69 year

Sex eligibility

Female

Study type

Observational

Primary location

Odense University Hospital, Odense, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participation in the Danish breast cancer screening program

Exclusion criteria

No clinical mammography conducted

Treatment and study plan

Primary outcomes

Correlation between blood samples and clinical mammography result

Time frame: 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.

Secondary outcomes

Correlation between blood samples and interval breast cancer

Time frame: From 6 weeks after the clinical mammography to next mammographyscreening, up to 3 years

The chance of being healthy is estimated from the combined blood sample results and will be compared to the interval cancers diagnosed in the study period.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

Sygehus Lillebaelt

Registry information

Official study title

OPTIMA: Optimising Mammography Assesment Via Blood-based Biomarkers

Acronym: OPTIMA

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2029
First posted: Jul 3, 2025
Registry last updated: Mar 9, 2026

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

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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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