Personalised Therapeutics @LUMC

NCT05508763 | Active Not Recruiting

• 1 other identifier: NL78161.058.21
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adverse Drug Reaction

Keywords

Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• ADRs grade >3 total

  The primary outcome will be the occurrence of clinically relevant (classified as NCI-CTCAE grade 3, 4, or 5) patient reported ADRs within one year of follow-up.

  One year

Secondary Outcomes (6)

• ADRs grade >3

  One, three, six and twelve months

• Acceptance to recommendations

  One year

• Cost-effectiveness

  One year

• ADRs grade >2 total

  One year

• ADRs grade >2

  One, three, six and twelve months

Other Outcomes (8)

• The number of drugs per patient.

  One year

• The number of ADRs per patient ≥ grade 3.

  One year

• The number of ADRs per patient ≥ grade 2.

  One year

Study Arms (2)

PGx-guided dosing

This group will be genotyped for 14 pharmacogenes at the start of the study.

Genetic: Genetic test for 14 pharmacogenes

Standard of care

This group will be genotyped for 14 pharmacogenes at the end of the study.

Interventions

Genetic test for 14 pharmacogenes GENETIC

Genotyping with the Global Diversity Array-8 v1.0 BeadChip with enhanced PGx

PGx-guided dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients of 18 years of age or older that participate in medication verification in the LUMC are eligible to participate.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactating
• Previous participation in the PREPARE trial (NCT03093818, NL60069.058.16)

Sponsors & Collaborators

• Leiden University Medical Center: lead
• bio.logis digital health GmbH: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy and Pharmacogenetics

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)