Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions

Sponsor
Nalagenetics Pte Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05504135
Collaborator
(none)
500
1
18
27.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pharmacogenomics Testing

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions
Anticipated Study Start Date :
Aug 22, 2022
Anticipated Primary Completion Date :
Feb 22, 2023
Anticipated Study Completion Date :
Feb 22, 2024

Arms and Interventions

Arm Intervention/Treatment
RMG Patients

Diagnostic Test: Pharmacogenomics Testing
To test if pharmacogenomics information (produced from testing) included by us in the Raffles' Electronic Health Records (EHR) will be used by physicians to personalize patients' prescriptions.

Outcome Measures

Primary Outcome Measures

  1. Turnaround time of genotype result, compared to expected [6 months]

  2. Overall satisfaction of patient [0 months]

    Via survey upon recruitment

  3. Overall satisfaction of patient [3 month]

    Via survey at month 3 of the study

  4. Overall satisfaction of patient [12 months]

    Via survey at month 12 of the study

  5. Overall satisfaction of site principal investigators [6 months]

    Via survey done at month 6 of the study

  6. Overall satisfaction of prescribing physicians [12 months]

    Via survey done at month 12 of the study

  7. 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.

  8. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Raffles Hospital Singapore Singapore 188770

Sponsors and Collaborators

  • Nalagenetics Pte Ltd

Investigators

  • Principal Investigator: Melvin Wong, Dr, Raffles Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nalagenetics Pte Ltd
ClinicalTrials.gov Identifier:
NCT05504135
Other Study ID Numbers:
  • SG-RMG-01-20190401
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 17, 2022