Clinical trial
Personalised Therapeutics @ Leiden University Medical Center
Name
NL78161.058.21
Description
In PT@LUMC 2000 patients will be randomized between a PGx-guided dosing group and a standard of care group. The patients will be followed for one year in which they will be asked to report adverse drug reactions at one, three, six and twelve months.
Trial arms
Trial start
2022-12-01
Estimated PCD
2024-09-01
Trial end
2024-10-01
Status
Recruiting
Treatment
Genetic test for 14 pharmacogenes
Genotyping with the Global Diversity Array-8 v1.0 BeadChip with enhanced PGx
Arms:
PGx-guided dosing
Size
2000
Primary endpoint
ADRs grade >3 total
One year
Eligibility criteria
Inclusion Criteria:
* Provision of informed consent (IC) prior to any study specific procedures.
* Be aged ≥18
* A venapunction as part of routine treatment
* Receive a medication verification interview
* Be able and willing to be followed-up for at least one year
Exclusion Criteria:
* Pregnancy or lactating
* Previous participation in the PREPARE trial (NCT03093818, NL60069.058.16)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EDTA blood'}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}
Updated at
2023-05-06
1 organization
1 product
1 indication
Organization
Leiden University Medical CenterIndication
Adverse Drug Reaction