Идёт набор NCT07734389

Genetic Assessment of Breast Cancer Risk in Women in the DORA Programme

Без фазы С лечением Breast Cancer Breast Cancer Risk

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: В протоколе указаны: Comprehensive Clinical and Genetic Breast Cancer Risk Assessment.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Breast Cancer Risk. Базовые параметры: 53 лет — 54 лет · 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: Словения
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Impact of Genetic Assessment on the Evaluation of Individual Breast Cancer Risk Among Women at Increased Risk in the DORA Programme

Обзор

This prospective study evaluates whether a more detailed clinical and genetic assessment can improve the classification of individual breast cancer risk among women previously identified as having moderately increased or high breast cancer risk in the Slovenian DORA breast cancer screening programme. Women who agree to participate complete questionnaires and attend an individual genetic counseling appointment at the Institute of Oncology Ljubljana. Personal breast cancer risk factors are reviewed with the assistance of a specialist, and reported family cancer history is verified using data from the Slovenian Cancer Registry. Breast cancer risk is reassessed using the S-IBIS and CanRisk models. Genetic testing is offered to participants who meet the applicable clinical criteria. The study will evaluate changes in breast cancer risk classification, compare risk estimates obtained using the S-IBIS and CanRisk models, and provide participants with individualized recommendations for breast cancer screening and follow-up according to their reassessed risk.

Подробное описание

This study is a continuation of a previous study conducted within the Slovenian DORA breast cancer screening programme. The previous study included women who turned 50 years of age in 2021, were invited for their first screening mammography in the DORA programme, completed a breast cancer risk questionnaire, and provided informed consent.

In the previous study, breast cancer risk was initially estimated using the S-IBIS model on the basis of questionnaire data and mammographic information. A total of 291 women were identified as having moderately increased or high breast cancer risk. Because the initial assessment was based mainly on self-reported information and did not include expert-assisted verification of all risk factors and family cancer history, these women are invited to participate in a more detailed risk assessment.

Participants who provide consent complete additional questionnaires and attend an individual consultation at the Department of Clinical Cancer Genetics of the Institute of Oncology Ljubljana. During the consultation, personal breast cancer risk factors and family cancer history are reviewed with a specialist. Reported cancer diagnoses in family members are verified, where possible, using the Slovenian Cancer Registry. Information collected includes personal characteristics, breast cancer risk factors, family history of cancer, breast tissue density, and genetic test results when genetic testing is performed.

Individual breast cancer risk is reassessed using the S-IBIS and CanRisk models. Genetic testing is offered when the participant meets the criteria defined in the applicable clinical guidelines. Following completion of the assessment, each participant receives recommendations for further breast cancer screening and follow-up according to her reassessed level of risk.

The study hypothesis is that more than half of the women initially classified as having increased breast cancer risk will be reclassified as having population-level risk after the detailed reassessment. The primary objective is to provide women who remain at moderately increased or high risk with more appropriate risk-adapted screening and follow-up. The secondary objective is to evaluate agreement between breast cancer risk estimates obtained using the S-IBIS and CanRisk models.

The study includes women previously classified as having moderately increased or high breast cancer risk. Women with a diagnosis of breast cancer are excluded. Data will be analyzed using descriptive statistical methods and will be processed in a pseudonymized form.

Вмешательства

Другое Comprehensive Clinical and Genetic Breast Cancer Risk Assessment
Participants receive an individual clinical and genetic breast cancer risk assessment. Personal risk factors are reviewed with the assistance of a specialist, and family cancer history is verified using the Slovenian Cancer Registry. Breast cancer risk is calculated using the S-IBIS and CanRisk models. Genetic counseling is provided, and genetic testing is performed when the participant meets the applicable clinical criteria. Recommendations for screening and follow-up are adapted to the reasses

Первичные конечные точки

Proportion of Participants Reclassified to Population-Level Breast Cancer Risk [Срок оценки: Through study completion, up to 34 months]

Вторичные конечные точки (1)

Agreement Between S-IBIS and CanRisk Breast Cancer Risk Classifications [Срок оценки: Through study completion, up to 34 months]

Критерии участия

Критерии включения

\- Women who participated in the previous DORA study and were classified by the S-IBIS model as having moderately increased or high breast cancer risk.