Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
Sponsor: University Hospital, Basel, Switzerland
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.
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2019-10-15
Completion Date
2026-08
Last Updated
2025-05-14
Healthy Volunteers
Yes
Conditions
Interventions
Buccal swab
Pharmacogenetic panel testing is conducted by Stratipharm with the DNA of the buccal swab. TaqMan® polymerase chain reaction is proceeded to express the genetic information. Stratipharm is a product offered by Humatrix Aktiengesellschaft (AG). It consists of a laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes, which code for transport proteins, metabolizing enzymes, or drug targets.
EDTA Blood sample (4.9mL)
Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.
Serum sample (7.5mL)
blood sample to determine the actual levels of the compound in patients on medication assumed to be associated to an observed ADR (phenotype).
communication of test results
Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician
unstructured interview
One and six months after the communication of test results, the study center will make a phone call to the patient for an unstructured interview in order to gather information about potential outcomes
Locations (1)
Department of Pharmaceutical Sciences, University Basel
Basel, Switzerland