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出境医 / 临床实验 / Personalised Risk-based Breast Cancer Prevention and Screening

Personalised Risk-based Breast Cancer Prevention and Screening

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Mammography outside official screening Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28389 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Implementation of a Model for Personalised Risk-Based Breast Cancer Prevention and Screening
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Cohort 1
High monogenic breast cancer risk
 Diagnostic Test: Mammography outside official screening
Radiologic study
Active Comparator: Cohort 2
High polygenic breast cancer risk
 Diagnostic Test: Mammography outside official screening
Radiologic study
No Intervention: Cohort StMG
Standard mammography screening in age 50-69
Outcome Measures
Primary Outcome Measures :
  1. Proportion of women in the population with genetically higher risk for breast cancer [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Number of screen-detected breast cancers in different risk groups [ Time Frame: 3-years ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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;
  • 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.

Exclusion Criteria:

Cohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.

Contacts and Locations

Locations
Layout table for location information
Estonia
Tartu University Hospital Recruiting
Tartu, Tartumaa, Estonia, 50406
Contact: Peeter Padrik, MD, PhD    +3727319800    peeter.padrik@kliinikum.ee   
The North Estonia Medical Centre Recruiting
Tallinn, Estonia, 13419
Contact: Vahur Valvere, MD,PhD    +3726172304    vahur.valvere@regionaalhaigla.ee   
Sponsors and Collaborators
Tartu University Hospital
University of Tartu
North Estonia Medical Centre
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		Proportion of women in the population with genetically higher risk for breast cancer [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		Number of screen-detected breast cancers in different risk groups [ Time Frame: 3-years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalised Risk-based Breast Cancer Prevention and Screening
Official Title  ICMJE Implementation of a Model for Personalised Risk-Based Breast Cancer Prevention and Screening
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE Diagnostic Test: Mammography outside official screening
Radiologic study
Study Arms  ICMJE
  • Active Comparator: Cohort 1
    High monogenic breast cancer risk
    Intervention: Diagnostic Test: Mammography outside official screening
  • Active Comparator: Cohort 2
    High polygenic breast cancer risk
    Intervention: Diagnostic Test: Mammography outside official screening
  • No Intervention: Cohort StMG
    Standard mammography screening in age 50-69
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		28389
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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;
  • 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.

Exclusion Criteria:

Cohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989258
Other Study ID Numbers  ICMJE estPerMed 1, Breast
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Peeter Padrik, Tartu University Hospital
Study Sponsor  ICMJE Tartu University Hospital
Collaborators  ICMJE
  • University of Tartu
  • North Estonia Medical Centre
Investigators  ICMJE Not Provided
PRS Account Tartu University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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