Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer
ConditionBreast Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female patients,
aged 18 years or older,
identified as high genetic risk by breast surgeons,
referred to a geneticist, and
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Through study completion, an average at one year.Secondary outcomes
1
Evaluate the rate of agreement between the AI tool and the breast surgeon
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.2
Agreement between hereditary breast cancer risk identified by the AI tool and the results of genetic testing.
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.3
Describe the rate of family history profile of women at high risk for breast cancer
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.4
Examine the rate of high penetrance variants
Examine the rate of high penetrance variants.
Time frame
Through study completion, an average at one year.Sponsors and contacts
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Source ClinicalTrials.gov