PREemptive Pharmacogenomic testing for prevention of Adverse drug REactions

Overview

Información sobre este estudio

The purpose of this study is to determine whether the implementation of pre-emptive PGx[HSR1]  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’). 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion 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.

Exclusion Criteria: 

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.
  • 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/13/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Elisa Houwink, M.D., Ph.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Mary Johnson CCRP

(507) 293-7891

Johnson.Mary15@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20562190

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