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

RecruitingOBSERVATIONAL
Enrollment

400

Participants

Timeline

Start Date

October 15, 2019

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Adverse Drug ReactionTherapy Failure
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

EDTA Blood sample (4.9mL)

Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.

DIAGNOSTIC_TEST

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).

OTHER

communication of test results

Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician

OTHER

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

Trial Locations (1)

4056

RECRUITING

Department of Pharmaceutical Sciences, University Basel, Basel

All Listed Sponsors
collaborator

Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel

UNKNOWN

collaborator

Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich

UNKNOWN

collaborator

Institut für Spitalpharmazie, Solothurner Spitäler AG, Baslerstrasse 150, 4600 Olten

UNKNOWN

lead

University Hospital, Basel, Switzerland

OTHER

NCT04154553 - Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure | Biotech Hunter | Biotech Hunter