Clinical trial · Observational
Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer
Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Agreement between AI tool results and genetic test results
- timeFrame
- Through study completion, an average at one year.
- description
- 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.
Secondary outcomes (6)
- measure
- Evaluate the rate of agreement between the AI tool and the breast surgeon
- timeFrame
- Through study completion, an average at one year.
- description
- Comparison between the number of participants who were indicated to genetic counseling through the AI tool and according to the opinion of the mastologist
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available