Breast CancerOPTIMANCT07049822
Optimising Mammography Screening Accuracy With Blood-based Biomarkers
An observational study of Breast Cancer, run by Vejle Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,200 participants
- Where
- 2 sitesDenmark
- Study dates
- 24 Nov 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women referred to a clinical mammography at Vejle Hospital or Odense University Hospital in the breast cancer screening program.
Who may be able to join
- Participation in the Danish breast cancer screening program
Who cannot join
- No clinical mammography conducted
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Odense University Hospital
Odense, 5000
Vejle Hospital
Vejle, 7100
About this study
Official title: OPTIMA: Optimising Mammography Assesment Via 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.
Read the 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
- Keywords
- Breast cancer screening, blood-based biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks from clinical mammography date
Secondary outcomes (1)
Correlation between blood samples and interval breast cancer
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.
Measured: From 6 weeks after the clinical mammography to next mammographyscreening, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start24 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Responsible party
- Sponsor
- Investigators
- Jonna S Madsen, Prof., MD, Study chair, Sygehus LillebaeltSisse H Njor, Professor, Study chair, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049822
- Sponsor's protocol ID
- 24/54432 - OPTIMA
- Acronym
- OPTIMA
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Danish regulations IPD is not allowed to be shared without direct approval from the individual. The outcomes of this study can be explored and presented without requiring IPD .
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMA: Optimising Mammography Assesment Via Blood-based Biomarkers
- ClinicalTrials.gov ID
- NCT07049822
- Acronym / sponsor ID
- OPTIMA / 24/54432 - OPTIMA
- Conditions
- Breast Cancer
- Keywords
- Breast cancer screening, blood-based biomarkers
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women referred to a clinical mammography at Vejle Hospital or Odense University Hospital in the breast cancer screening program.
Key inclusion criteria (1 listed)
- Participation in the Danish breast cancer screening program
Key exclusion criteria (1 listed)
- No clinical mammography conducted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation between blood samples and interval breast cancer
Time frame: From 6 weeks after the clinical mammography to next mammographyscreening, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. Due to Danish regulations IPD is not allowed to be shared without direct approval from the individual. The outcomes of this study can be explored and presented without requiring IPD .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonna S Madsen, Prof., MD study chair
Sygehus Lillebaelt
Sisse H Njor, Professor study chair
Sygehus Lillebaelt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Vejle Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between blood samples and clinical mammography result (time frame: 6 weeks from clinical mammography date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.