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Optimising Mammography Screening Accuracy With Blood-based Biomarkers

OPTIMA: Optimising Mammography Assesment Via Blood-based Biomarkers

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07049822
Acronym
OPTIMA
Enrollment
1200
Registered
2025-07-03
Start date
2025-11-24
Completion date
2029-12-31
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer screening, blood-based biomarkers

Brief summary

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.

Interventions

None listed

Sponsors

Vejle Hospital
Lead SponsorOTHER
Sygehus Lillebaelt
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Participation in the Danish breast cancer screening program

Exclusion criteria

* No clinical mammography conducted

Design outcomes

Primary

MeasureTime frameDescription
Correlation between blood samples and clinical mammography result6 weeks from clinical mammography dateThe 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

MeasureTime frameDescription
Correlation between blood samples and interval breast cancerFrom 6 weeks after the clinical mammography to next mammographyscreening, up to 3 yearsThe 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.

Countries

Denmark

Contacts

STUDY_CHAIRJonna S Madsen, Prof., MD

Sygehus Lillebaelt

STUDY_CHAIRSisse H Njor, Professor

Sygehus Lillebaelt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026