Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer
STAR-BREAST
1 other identifier
observational
800
1 country
3
Brief Summary
It is a retrospective observational study that will include female patients aged 18 years or older, who were treated between 2017 and 2024, in both public and private institutions, and identified as at high genetic risk by breast specialists and referred to a geneticist. The artificial intelligence-based tool to be used in this study is developed by the startup WeConecta, which will collect data via WhatsApp about the patients' family cancer history with the aim of predicting the genetic risk of developing breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 11, 2026
July 29, 2026
July 1, 2026
12 months
April 16, 2025
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement between AI tool results and genetic test results
Implement the use of an artificial intelligence (AI)-based tool, WeConecta, to predict the genetic risk of hereditary breast cancer in women treated at a private and public institution, including analyses of the sensitivity, specificity, and positive and negative predictive values of the tool in comparison with the results of the genetic test. Hypothesis: The artificial intelligence (AI)-based tool may present a strong level of agreement regarding the indication for genetic counseling in relation to the indication of mastologists, impacting genetic testing.
Through study completion, an average at one year.
Secondary Outcomes (6)
Evaluate the rate of agreement between the AI tool and the breast surgeon
Through study completion, an average at one year.
Agreement between hereditary breast cancer risk identified by the AI tool and the results of genetic testing.
Through study completion, an average at one year.
Describe the rate of family history profile of women at high risk for breast cancer
Through study completion, an average at one year.
Examine the rate of high penetrance variants
Through study completion, an average at one year.
Describe the rate of profile of patients with confirmed BRCA1 and BRCA2 variants
Through study completion, an average at one year.
- +1 more secondary outcomes
Eligibility Criteria
Convenience sampling will be performed, inviting all women treated at both institutions from January 2017 to June 2024 who have been considered by breast surgeons as genetic risk patients and have undergone genetic testing with a geneticist, regardless of whether they have invasive breast carcinoma.
You may qualify if:
- female patients,
- aged 18 years or older,
- identified as high genetic risk by breast surgeons,
- referred to a geneticist, and
- who agree to participate in the study.
You may not qualify if:
- male patients,
- absence of complete information in the medical records,
- patients unaware of their biological family history, and
- patients who do not agree to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Golania, Goiás, 74605-020, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2025
First Posted
July 17, 2025
Study Start
August 20, 2025
Primary Completion (Estimated)
August 11, 2026
Study Completion (Estimated)
August 11, 2026
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.