Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)
Overview
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.
Detailed description
This is an observational retrospective study. Patients considered by mastologists to be at genetic risk and who have undergone genetic testing with a geneticist will have their electronic medical records reviewed and, if eligible for the study, will answer questions conducted by the virtual assistant using AI about their family history of cancer.
This study will be conducted in two centers. The first is the Breast Center at Hospital Moinhos de Vento, designated as the coordinating center, located in Porto Alegre, Rio Grande do Sul, Brazil. It is a private center composed of a multidisciplinary team dedicated to breast health care, from routine exams for early detection of malignant tumors, diagnosis, comprehensive treatment at different stages of the disease, to post-treatment follow-up. The second center, designated as a participant, is the Human Genetics Center (CEGH/ICB), located in Goiânia, Brazil. This entity works interdisciplinarily and is linked to the Institute of Biological Sciences at the Federal University of Goiás (UFG), with the aim of developing activities in diagnosis, education, research, and outreach in the field of human genetics.
CEGH/ICB is a public institution that serves women with breast cancer from the Unified Health System (SUS), and its role in the research is to share collected data from the population of interest with the coordinating center.
Primary outcome measures
- Agreement between AI tool results and genetic test results [Time frame: Through study completion, an average at one year.]
Secondary outcome measures (6)
- Evaluate the rate of agreement between the AI tool and the breast surgeon [Time frame: 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. [Time frame: Through study completion, an average at one year.]
- Describe the rate of family history profile of women at high risk for breast cancer [Time frame: Through study completion, an average at one year.]
- Examine the rate of high penetrance variants [Time frame: Through study completion, an average at one year.]
- Describe the rate of profile of patients with confirmed BRCA1 and BRCA2 variants [Time frame: Through study completion, an average at one year.]
- Compare the rate of patient profiles between the two institutions [Time frame: Through study completion, an average at one year.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Brazil · 3 centers
- Research Site — Golania
- Research Site — Porto Alegre
- Research Site — Porto Alegre
Identifiers
NCT: NCT07070128 · D0817R00113