Pre-emptive PharmacogenomicsNCT05504135
Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (IMPT Study)
An observational study of Pre-emptive Pharmacogenomics, run by Nalagenetics Pte Ltd at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pre-emptive Pharmacogenomics
- What is being tested?
- Pharmacogenomics Testing
- How many people
- 222 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Oct 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 250 patients visiting Raffles Hospital in Singapore
Who may be able to join
- Patients who experienced at least one of the following diseases, or is at risk of developing them:
- Diabetes Mellitus
- Hypertension
- Hyperlipidaemia
- Ischaemic Heart Disease
- Stroke
Show all 11Show fewer
- Osteoarthritis
- Rheumatoid Arthritis
- Gout
- Anxiety
- Major Depression
Who cannot join
- Below ages 21 and above ages 65
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pre-emptive Pharmacogenomics
- Being tested
- Pharmacogenomics Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomics TestingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| RMG Patients | Not described Receives: Diagnostic Test: Pharmacogenomics Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turnaround time of genotype result, compared to expected
Measured: 6 months
Overall satisfaction of patient
Via survey upon recruitment
Measured: 0 months
Overall satisfaction of patient
Via survey at month 3 of the study
Measured: 3 month
Overall satisfaction of patient
Via survey at month 12 of the study
Measured: 12 months
Overall satisfaction of site principal investigators
Via survey done at month 6 of the study
Measured: 6 months
Overall satisfaction of prescribing physicians
Via survey done at month 12 of the study
Measured: 12 months
Prevalence of clinically actionable genotypes
The number of patients receiving recommendations that includes a certain follow up action which includes monitoring, change of dosing or change of prescription.
Measured: 12 months
Recommendation acceptance rate
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start3 Oct 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-emptive PharmacogenomicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalagenetics Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melvin Wong, Dr, Principal investigator, Raffles Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504135
- Sponsor's protocol ID
- SG-RMG-01-20190401
- Status last verified
- May 2025
- First submitted
- 11 Aug 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng FF, Verma R, Sani L, Irwanto A, Lee M, Wee A, Chng SK, Wong M, Chan A. A feasibility study on implementing pre-emptive pharmacogenomics testing in outpatient clinics in Singapore (IMPT study). Pharmacogenomics J. 2025 Mar 12;25(1-2):7. doi: 10.1038/s41397-025-00366-1.
PubMed 40074758
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (IMPT Study)
- ClinicalTrials.gov ID
- NCT05504135
- Acronym / sponsor ID
- SG-RMG-01-20190401
- Conditions
- Pre-emptive Pharmacogenomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Nalagenetics Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RMG Patients | – | Diagnostic Test: Pharmacogenomics Testing |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250 patients visiting Raffles Hospital in Singapore
Key inclusion criteria (11 listed)
- Patients who experienced at least one of the following diseases, or is at risk of developing them:
Key exclusion criteria (1 listed)
- Below ages 21 and above ages 65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomics TestingTo 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. | Diagnostic test | RMG Patients |
Primary outcome
Turnaround time of genotype result, compared to expected
Time frame: 6 months
Overall satisfaction of patient
Time frame: 0 months
Via survey upon recruitment
Overall satisfaction of patient
Time frame: 3 month
Via survey at month 3 of the study
Overall satisfaction of patient
Time frame: 12 months
Via survey at month 12 of the study
Overall satisfaction of site principal investigators
Time frame: 6 months
Via survey done at month 6 of the study
Overall satisfaction of prescribing physicians
Time frame: 12 months
Via survey done at month 12 of the study
Prevalence of clinically actionable genotypes
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 40074758Ng FF, Verma R, Sani L, Irwanto A, Lee M, Wee A, Chng SK, Wong M, Chan A. A feasibility study on implementing pre-emptive pharmacogenomics testing in outpatient clinics in Singapore (IMPT study). Pharmacogenomics J. 2025 Mar 12;25(1-2):7. doi: 10.1038/s41397-025-00366-1.
- Individual participant dataSharing planned: No
Related trials for Pre-emptive Pharmacogenomics
Recruiting
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Pharmacogenomic Drug Interaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melvin Wong, Dr principal investigator
Raffles Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-emptive Pharmacogenomics, run by Nalagenetics Pte Ltd at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turnaround time of genotype result, compared to expected (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.