Breast CancerNCT03989258
Personalised Risk-based Breast Cancer Prevention and Screening
A study testing Mammography outside official screening in people with Breast Cancer, run by Tartu University Hospital at 2 sites in Estonia.
Trial summary
This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mammography outside official screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,389 participants
- Where
- 2 sitesEstonia
- Study dates
- 1 Oct 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1:
- Available NGS (WGS or WES) data for detection of breast cancer moderate to high genetic risk variants in BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
- Available genetic (WGS, genotyping) data for PRS calculation, participants in age 40-74 will be further selected;
- Cohort 2:
- Available genotyping data;
- No available NGS data for BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
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- Participants in the age group 40-74 with available genetic data for PRS calculation;
- Cohort StMG:
- Female participants in Estonian Biobank in the age group 50-69 participating at least once in the current Estonian population-based screening program during 2016-2020.
Who cannot join
- Cohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.
Trial locations and contacts
2 sites in 1 country.
Estonia2 sites, 2 recruiting
- Recruiting
The North Estonia Medical Centre
Tallinn, 13419
Vahur Valvere, MD,PhD, +3726172304, vahur.valvere@regionaalhaigla.ee
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Peeter Padrik, MD, PhD, +3727319800, peeter.padrik@kliinikum.ee
About this study
Official title: Implementation of a Model for Personalised Risk-Based Breast Cancer Prevention and Screening
This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.
- Conditions
- Breast Cancer
- Being tested
- Mammography outside official screening
- Keywords
- Breast cancer, Screening, Genetic risk, Polygenic risk score
- Medical subject headings
- Breast Neoplasms, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography outside official screeningDiagnostic test
Radiologic study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | High monogenic breast cancer risk Receives: Diagnostic Test: Mammography outside official screening |
| Cohort 2 | Active comparator | High polygenic breast cancer risk Receives: Diagnostic Test: Mammography outside official screening |
| Cohort StMG | No intervention | Standard mammography screening in age 50-69 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women in the population with genetically higher risk for breast cancer
Measured: 3 years
Secondary outcomes (1)
Number of screen-detected breast cancers in different risk groups
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Oct 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28,389 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu, North Estonia Medical Centre
- Responsible party
- Principal investigator, Peeter Padrik, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989258
- Sponsor's protocol ID
- estPerMed 1, Breast
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Model for Personalised Risk-Based Breast Cancer Prevention and Screening
- ClinicalTrials.gov ID
- NCT03989258
- Acronym / sponsor ID
- estPerMed 1, Breast
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Screening, Genetic risk, Polygenic risk score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28,389 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- University of Tartu, North Estonia Medical Centre
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Jun 2019 (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.
This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Diagnostic Test: Mammography outside official screeningHigh monogenic breast cancer risk |
| Cohort 2 | Active comparator | Diagnostic Test: Mammography outside official screeningHigh polygenic breast cancer risk |
| Cohort StMG | No intervention | –Standard mammography screening in age 50-69 |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Available NGS (WGS or WES) data for detection of breast cancer moderate to high genetic risk variants in BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
- Available genetic (WGS, genotyping) data for PRS calculation, participants in age 40-74 will be further selected;
- Available genotyping data;
- No available NGS data for BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
- Participants in the age group 40-74 with available genetic data for PRS calculation;
Key exclusion criteria (1 listed)
- Cohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.
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 |
|---|---|---|
| Mammography outside official screeningRadiologic study | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
Proportion of women in the population with genetically higher risk for breast cancer
Time frame: 3 years
1 secondary outcome
Number of screen-detected breast cancers in different risk groups
Time frame: 3-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography outside official screening in people with Breast Cancer, run by Tartu University Hospital at 2 sites in Estonia.
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 9 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: status not confirmed, as of the sponsor's last update on 20 Jun 2019. 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 Estonia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women in the population with genetically higher risk for breast cancer (time frame: 3 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 20 Jun 2019.