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Идёт набор NCT07197723

Study of How People Make Decisions About Prostate Cancer Risk

— Наблюдательное BRCA1/2 Geneitic Testing

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: cheek (buccal) swab, Assessments, optional collection of blood.
Кому может быть актуально
Состояния в реестре: BRCA1/2, Geneitic Testing. Базовые параметры: 45 лет — 70 лет · Мужчины.
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

Effect of Polygenic Risk Modifiers on Decisions of BRCA1/2 Mutation Carriers at Risk for Prostate Cancer

Обзор

The purpose of this study is to learn how people with BRCA1/2 mutations respond to genetic risk modifier testing. The researchers will learn more about how people make choices about their health care, including about methods to screen for prostate cancer. Researchers are also doing this study to learn about how the genetic risk modifier test affects people's thoughts and feelings.

Вмешательства

  • Генная терапия cheek (buccal) swab
    swab sample in person or at home with a mailed test kit and will fill out a survey
  • Другое Assessments
    about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.
  • Другое optional collection of blood
    for research testing

Первичные конечные точки

  • Intention to undergo prostate cancer screening options [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Documentation of Disease

o Patients must not have prostate cancer (for individuals not presently receiving care at the study site, this information will be based on self-report.)

  • Age between 45 - 70;
  • Assigned male sex at birth for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Completed full sequence or targeted genetic testing with a result confirmed in a clinically approved laboratory showing a BRCA1/2 likely pathogenic or pathogenic variant identified, or clinician note documents a BRCA1/2 likely pathogenic or pathogenic variant
  • English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.(for individuals not presently receiving care at the study site, this information will be based on self-report.)

Критерии исключения

  • Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
  • Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
  • Under active treatment for a malignancy. (Patients are eligible if they have a prior history of malignancy other than prostate cancer, as long as they are not currently undergoing active treatment for the malignancy) (for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report
  • Patients with a known pathogenic and/or likely pathogenic germline variant in any hereditary prostate cancer risk gene, excluding BRCA1 and/or BRCA2, including but not limited to: HOXB13, ATM, CHEK2, NBN, PALB2, MLH1, MSH2, MSH6, PMS2,RAD51C, RAD51D and TP53.
  • Any patient who has had a prostate biopsy within 36 months, according to clinician note (for individuals not presently receiving care at the study site, this information will be based on self-report)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT07197723 · 25-235

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗