Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    100
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 17 February 2022
pharmacogenomic testing
Accepts healthy volunteers

Summary

Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.

Description

Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. Health-related data of patients experiencing therapy failure (TF) or adverse drug reaction (ADR) is collected and will then be supplemented with pharmacogenetic testing during pharmaceutical care in a study pharmacy. The patient data (diagnoses, medications and results of pharmacogenetic testing) is harmonized in order to generate a compilation of case reports. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.

Details
Condition Adverse Drug Reaction, Therapy Failure
Treatment Buccal swab, EDTA Blood sample (4.9mL), Serum sample (7.5mL), communication of test results, unstructured interview
Clinical Study IdentifierNCT04154553
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on17 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

New medication with known PGx association (preemptive)
Current medication with observation of adverse drug reactions probably linked to drugs with known PGx association (reactive)
Current medication with observation of therapy failure probably linked to drugs with known PGx association (reactive)
Current and/or new medication and a family history of adverse drug reactions/therapy failure probably linked to drugs with known PGx association
Signed informed consent

Exclusion Criteria

Insufficient German knowledge
Not able to personally visit to the study pharmacy
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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