NCT Number: NCT07070128
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.
Interested in participating?
Request InfoFemale
Observational
Research Site, Golania, Goiás, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion, an average at one year.
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.
Time frame: Through study completion, an average at one year.
Comparison between the number of participants who were indicated to genetic counseling through the AI tool and according to the opinion of the mastologist
Time frame: Through study completion, an average at one year.
To assess how many patients were identified by the AI tool as having "hereditary breast cancer risk" and how closely they agreed with the actual number obtained from genetic testing results.
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 patients with pathogenic variants and genetic risk of breast cancer between the two institutions involved in the study.
Interested in participating?
Request InfoAstraZeneca
Industry
Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)
Acronym: STAR-BREAST
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