Optimising Mammography Screening Accuracy With Blood-based Biomarkers

NCT ID: NCT07049822

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-12-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participation in the Danish breast cancer screening program

Exclusion Criteria

• No clinical mammography conducted

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sygehus Lillebaelt

OTHER

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonna S Madsen, Prof., MD

Role: STUDY_CHAIR

Sygehus Lillebaelt

Sisse H Njor, Professor

Role: STUDY_CHAIR

Sygehus Lillebaelt

Locations

Odense University Hospital

Odense, , Denmark

Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Central Contacts

Anne Mette Kristensen, M.Sc Computational biomedicine

Role: CONTACT

anne.mette.kaag.kristensen@rsyd.dk

+4521640589

Facility Contacts

Anne Mette Kristensen, M.Sc Computaional Biomedicine

Role: primary

anne.mette.kaag.kristensen@rsyd.dk

+45 21640589

Anne Mette Kristensen, M.Sc Computaional Biomedicine

Role: primary

anne.mette.kaag.kristensen@rsyd.dk

+45 21640589

Other Identifiers

24/54432 - OPTIMA

Identifier Type: -

Identifier Source: org_study_id