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Идёт набор NCT06322238

Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

Фаза II С лечением Pharmacogenomic Drug Interaction Side Effect of Drug Ineffective Drug Action Drug Metabolism, Poor, CYP2D6-Related

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: PGx panel test.
Кому может быть актуально
Состояния в реестре: Pharmacogenomic Drug Interaction, Side Effect of Drug, Ineffective Drug Action, Drug Metabolism, Poor, CYP2D6-Related. 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

A Multi-gene Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: Open-label, Mayo Clinic Multisite (Mayo Clinic Health System-Rochester Primary Care), Controlled, Implementation Study Taking the Results of the PREPARE Study Into Minnesota (PREPARE-Mayo)

Обзор

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').

Вмешательства

  • Диагностический тест PGx panel test
    In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Первичные конечные точки

  • Adverse Drug Reaction (ADR) [Срок оценки: 48 weeks]
Вторичные конечные точки (2)
  • PREPARE-MAYO Clinicians' and pharmacists' Questionnaire. [Срок оценки: 48 weeks]
  • Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire [Срок оценки: 48 weeks]

Критерии участия

Критерии включения

  • Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Subject must be ≥ 18 years old
  • Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.
  • Subject is able and willing to take part and willing to be followed up on for 48 weeks
  • Subject is able to donate saliva
  • Subject has signed informed consent
  • Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

Критерии исключения

  • For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
  • Pregnant or lactating (to be verbally confirmed with the patient)
  • Life expectancy estimated to be less than three months as determined by patient receiving hospice care
  • Duration of index drug total treatment length is planned to be less than seven consecutive days.
  • Current inpatients
  • Unable to consent to the study
  • Unwilling to take part
  • Subject has no permanent address
  • Subject has no current primary care provider
  • Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
  • Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
  • Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
  • History of a liver transplant or an allogeneic hematopoietic stem cell transplant
  • DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT06322238 · 23-008706

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗