Breast CancerNCT05731453
Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
A study testing Polygenetic risk score in people with Breast Cancer, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Polygenetic risk score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2023to 11 Nov 2035
- Phase
- Interventional
- 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 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women referred for clinical mammography in the Vestre Viken Breast Centre
- Breast density BI-RADS a or d
- 40-50 y.o.
Who cannot join
- Prior history of breast cancer or premalignant breast disease
- Prior genetic counselling/testing
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.
Read the detailed description
The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.
- Conditions
- Breast Cancer
- Being tested
- Polygenetic risk score
- Keywords
- risk based screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygenetic risk scoreGenetic
Polygenetic risk score assessment for breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Polygenetic risk score | Experimental | Assessment of polygenetic risk score for breast cancer Receives: Genetic: Polygenetic risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of breast cancer risk by polygenetic risk score in the study population
Polygenetic breast cancer risk score (PRS) as a numeric value with 10 percentile, as absolute 10-year breast cancer risk, and as relative risk compared with average women at the same age
Measured: 10 years
Secondary outcomes (3)
Compliance to individual recommedations for breast cancer screening
Percentage and frequencies of participants following their individual screening recommendations
Measured: 10 years
Correlation of polygenetic risk score and breast cancer risk assessed by family history
Distribution of PRS among participants with increased breast cancer risk based on family history
Measured: 10 years
Participants´ experience with study participation
Questionnaries on experience with the sampling process and feedback on a categorical scale (totally disagree, disagree, neutral, agree, totally agree)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Feb 2023
- Primary completion1 May 2024
- Study completion11 Nov 2035 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Tone Hovda, Phd, Principal investigator, Vestre Viken HT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731453
- Sponsor's protocol ID
- 494936
- Status last verified
- May 2024
- First submitted
- 10 Jan 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT05731453
- Acronym / sponsor ID
- 494936
- Conditions
- Breast Cancer
- Keywords
- risk based screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 11 Nov 2035 (estimated)
- First posted
- 16 Feb 2023 (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 study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.
Detailed description
The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polygenetic risk score | Experimental | Genetic: Polygenetic risk scoreAssessment of polygenetic risk score for breast cancer |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women referred for clinical mammography in the Vestre Viken Breast Centre
- Breast density BI-RADS a or d
- 40-50 y.o.
Key exclusion criteria (2 listed)
- Prior history of breast cancer or premalignant breast disease
- Prior genetic counselling/testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygenetic risk scorePolygenetic risk score assessment for breast cancer | Genetic | Polygenetic risk score |
Primary outcome
Assessment of breast cancer risk by polygenetic risk score in the study population
Time frame: 10 years
Polygenetic breast cancer risk score (PRS) as a numeric value with 10 percentile, as absolute 10-year breast cancer risk, and as relative risk compared with average women at the same age
3 secondary outcomes
Compliance to individual recommedations for breast cancer screening
Time frame: 10 years
Correlation of polygenetic risk score and breast cancer risk assessed by family history
Time frame: 10 years
Participants´ experience with study participation
Time frame: 10 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 23 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tone Hovda, Phd principal investigator
Vestre Viken HT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygenetic risk score in people with Breast Cancer, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Assessment of breast cancer risk by polygenetic risk score in the study population (time frame: 10 years). 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 23 May 2024.