Optimising Mammography Screening Accuracy With Blood-based Biomarkers

NCT07049822 | Enrolling By Invitation

• 1 other identifier: 24/54432 - OPTIMA
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Breast cancer screening; blood-based biomarkers

Outcome Measures

Primary Outcomes (1)

• Correlation between blood samples and clinical mammography result

  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.

  6 weeks from clinical mammography date

Secondary Outcomes (1)

• Correlation between blood samples and interval breast cancer

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

Study Arms (1)

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

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women referred to a clinical mammography at Vejle Hospital or Odense University Hospital in the breast cancer screening program.

You may qualify if:

• Participation in the Danish breast cancer screening program

You may not qualify if:

• No clinical mammography conducted

Sponsors & Collaborators

• Vejle Hospital: lead
• Sygehus Lillebaelt: collaborator

Study Sites (2)

Odense University Hospital

Odense, 5000, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonna S Madsen, Prof., MD

  Sygehus Lillebaelt

  STUDY CHAIR

• Sisse H Njor, Professor

  Sygehus Lillebaelt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)