Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (IMPT Study)

Active, not recruiting

• Conditions: Pre-emptive Pharmacogenomics
• Interventions: Diagnostic Test: Pharmacogenomics Testing

• Registration Number: NCT05504135
• Lead Sponsor: Nalagenetics Pte Ltd

Brief Summary

In collaboration with Raffles Medical Group, we will be recruiting 500 patients and following them for the next 3-12 months to see whether pharmacogenomics information provided in the Raffles' Electronic Health Records (EHR) will be used by physicians to personalize patients' prescriptions.

Detailed Description

Pre-emptive genotyping provides relevant genomic data to physicians to facilitate prescribing and to facilitate checking of prescriptions by pharmacists to ensure drug safety and efficacy. This essential information should be incorporated into electronic healthcare systems and should be readily available. The effectiveness of pre-emptive genotyping to reduce adverse drug reactions (ADRs) is unknown in Singapore. Hence, this study is designed to evaluate whether it is feasible to implement large scale pre-emptive genotyping program at a hospital in Singapore and aim to integrate genomic medicine into clinical practice to improve drug safety and efficacy.

This study involves the testing of feasibility of pharmacogenomic genotyping in hospitals whereby our pharmacogenomics panel tests for 5 genes (CYP2D6, CYP2C9, CYP2C19, SLCO1B1 and HLA-B\*58:01) which influences patient's response to more than 165 medications. Reports will be generated for all drugs that have been reported to be in CPIC Level A/B of association with the genes/haplotypes. The patients who are given these tests for free are recommended due to having experienced at least one of the diseases in our list or is at a risk of developing them.

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-14
• Study First Posted: 2022-08-17
• Study Start: 2022-10-03
• Primary Completion: 2023-08-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• Patients who experienced at least one of the following diseases, or is at risk of developing them:

  1. Diabetes Mellitus
  2. Hypertension
  3. Hyperlipidaemia
  4. Ischaemic Heart Disease
  5. Stroke
  6. Osteoarthritis
  7. Rheumatoid Arthritis
  8. Gout
  9. Anxiety
  10. Major Depression

Exclusion Criteria

• Below ages 21 and above ages 65

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RMG Patients	Pharmacogenomics Testing	-

Primary Outcome Measures

Name	Time	Method
Overall satisfaction of patient	12 months	Via survey at month 12 of the study
Turnaround time of genotype result, compared to expected	6 months
Overall satisfaction of site principal investigators	6 months	Via survey done at month 6 of the study
Overall satisfaction of prescribing physicians	12 months	Via survey done at month 12 of the study
Prevalence of clinically actionable genotypes	12 months	The number of patients receiving recommendations that includes a certain follow up action which includes monitoring, change of dosing or change of prescription.
Recommendation acceptance rate	12 months	Defined by: (1) Number of physicians who are interested to consider pharmacogenomics information to guide prescription, measured by click-through rate of Pharmacogenomics Access Button; (2) Number of changes made to the medications post-PGx testing; (3) Data obtained from satisfaction survey for prescribing physicians

Trial Locations

Locations (1)

Raffles Hospital; 🇸🇬 Singapore, Singapore