Clinical trial NCT05504135: Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (IMPT Study)
Official title: Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (IMPT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-emptive Pharmacogenomics
Lead sponsor: Nalagenetics Pte Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 222
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 patients visiting Raffles Hospital in Singapore

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.

Eligibility criteria: 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

Primary outcomes:
measure: Turnaround time of genotype result, compared to expected
timeFrame: 6 months
measure: Overall satisfaction of patient
timeFrame: 0 months
measure: Overall satisfaction of patient
timeFrame: 3 month
measure: Overall satisfaction of patient
timeFrame: 12 months
measure: Overall satisfaction of site principal investigators
timeFrame: 6 months
measure: Overall satisfaction of prescribing physicians
timeFrame: 12 months
measure: Prevalence of clinically actionable genotypes
timeFrame: 12 months
measure: Recommendation acceptance rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Raffles Hospital
Study officials:
affiliation: Raffles Medical Group
name: Melvin Wong, Dr
role: PRINCIPAL_INVESTIGATOR
References: