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Идёт набор NCT06927947

Navigation Interventions to Improve Cascade Genetic Testing Among Relatives of Patients With Hereditary Cancer Syndromes

Без фазы С лечением Hereditary Malignant Neoplasm Hereditary Neoplastic Syndrome

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: Communication Intervention, Health Promotion and Education, Informational Intervention, Survey Administration.
Кому может быть актуально
Состояния в реестре: Hereditary Malignant Neoplasm, Hereditary Neoplastic Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
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

Testing Effectiveness of Navigation Interventions to Increase Uptake of Cascade Genetic Testing Among Relatives of Individuals Diagnosed With Hereditary Cancer Syndromes

Обзор

This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. Once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. The uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. The Cascade Genetic Testing Platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. Using the Cascade Genetic Testing Platform may improve ways to share information about hereditary risk with biological relatives.

Подробное описание

03JUN2025- Amendment was approved that shorten the study timeline from 12 to 6 months. We believe this is sufficient to capture our primary outcome (participation) and a shorter timeline may keep participants more engaged.

22MAY2026- Amendment was approved adjusting enrollment goals to account for new accrual of prospective probands and their relatives, and to clarify realistic expectations for relative enrollment numbers.

Вмешательства

  • Другое Communication Intervention
    Use relative invitation tool
  • Другое Health Promotion and Education
    Receive access to the VGN
  • Другое Informational Intervention
    Receive access to a Genetic Testing Family Letter
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Percentage of probands that utilize the invitation tool [Срок оценки: Up to 6 Months]
  • Percentage of invited relatives that engage [Срок оценки: Up to 6 Months]
Вторичные конечные точки (3)
  • Extent of utilization of the invitation portal by probands [Срок оценки: Up to 6 Months]
  • Percentage of relatives invited who subsequently enroll in the study [Срок оценки: Up to 6 Months]
  • Percentage of relative participants who have either scheduled or completed genetic testing [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

  • PROBANDS: Clinically confirmed autosomal dominant pathogenic germline variant (PGV) associated with a hereditary cancer syndrome
  • PROBANDS: Previous evaluation by the University of Michigan (U-M) Cancer Genetics Clinic
  • PROBANDS: ≥ 18 years old
  • PROBANDS: Able to speak and read English
  • PROBANDS: Access to the internet
  • RELATIVES: Biological relative of proband
  • RELATIVES: ≥ 18 years old
  • RELATIVES: Able to speak and read English
  • RELATIVES: Access to the internet
  • RELATIVES: Have not completed germline genetic testing, per self-report at baseline

Критерии исключения

  • RELATIVES: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider, per self-report at baseline

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Идентификаторы

NCT: NCT06927947 · UMCC 2024.087 · NCI-2025-02246 · HUM00257832

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗