Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Neoplasms. Базовые параметры: Без ограничений · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Agreement between AI tool results and genetic test results [Срок оценки: Through study completion, an average at one year.]
Вторичные конечные точки (6)
- Evaluate the rate of agreement between the AI tool and the breast surgeon [Срок оценки: 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. [Срок оценки: Through study completion, an average at one year.]
- Describe the rate of family history profile of women at high risk for breast cancer [Срок оценки: Through study completion, an average at one year.]
- Examine the rate of high penetrance variants [Срок оценки: Through study completion, an average at one year.]
- Describe the rate of profile of patients with confirmed BRCA1 and BRCA2 variants [Срок оценки: Through study completion, an average at one year.]
- Compare the rate of patient profiles between the two institutions [Срок оценки: Through study completion, an average at one year.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Бразилия · 3 центра
- Research Site — Golania
- Research Site — Porto Alegre
- Research Site — Porto Alegre
Идентификаторы
NCT: NCT07070128 · D0817R00113