PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)

NCT06907784 | Recruiting DMC

• 1 other identifier: INGN24MG113
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 5

Brief Summary

It is known that individuals respond differently to the same medicine with some people benefitting, some experiencing no effect and others suffering side-effects or even coming to harm. Some of the differences in response to medications can be explained by our genes. Genes are short sections of DNA. Each individual has over 20,000 different genes. Genes carry instructions for making the proteins needed to build things within the body including the sites where medicines act. Pharmacogenomics is the study of how our genes affect the way our body responds to medications. Doctors can test for gene variations that might put an individual at risk of severe side-effects or mean that they are likely to receive no benefit from a specific medicine. Though not widely available in the NHS, testing allows doctors and patients to chose a different dose or avoid the medicine completely. It is estimated that almost everyone in the population (\>95%) carries at least one gene variation that affects our response to medicines. The PHOENIX study will recruit 4,000 participants who are admitted to hospital or attend an outpatient clinic who require a new drug prescription. The new drug prescription will be one who known pharmacogenomic implications. A cheek (buccal) swab will be taken which can be used to test a large number of genes known to alter the response to medicines. Around half of the participants will be tested immediately whilst the other half will have the test after three months. The results of the test relevant to each patients new prescription will enable the doctor prescribing to determine if any changes to that medicine would be beneficial. Information will be collected about participants quality of life, subsequent admissions to hospital, medication changes and side-effects. An assessment of cost saving to the NHS will also be made.

Conditions

Pharmacogenomic Drug Interaction

Keywords

Gene-drug; Gene panel; Polypharmacy; Adverse drug reaction; Health economics; pharmacogenomics

Outcome Measures

Primary Outcomes (1)

• Composite of ADRs and/or treatment failures

  Composite of ADRS (CTCAE ≥2) and/or treatment failures (applies to specific drugs where treatment failure is captured by hospital admissions with the condition for which the index drug was commenced).

  3 months

Secondary Outcomes (16)

• 5-level EQ-5D version (EQ-5D-5L) EuroQol

  3 months

• PGx Result Utilisation in Intervention Arm

  3 months

• PGx Result Utilisation in Standard Care Arm (Post-Delayed Genotyping)

  3 months

• Frequency of Actionable Genotypes at Baseline

  7 days

• Frequency of Actionable Genotypes for New Prescriptions During Follow-Up

  7 days - 3 months

Other Outcomes (6)

• Sub-group analysis- Age

  3 months

• Sub-group analysis - Sex

  3 months

• Sub-group analysis- Scottish Index of Multiple Deprivation (SIMD)

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Pharmacogenomic testing will be performed immediately in the intervention group with any resultant drug change by the treating clinician

Diagnostic Test: Pharmacogenomic testing

Standard of Care

OTHER

Pharmacogenomic testing (from the stored buccal swab sample) will be performed only at three months in the standard of care arm group with any resultant drug change by the treating clinician.

Diagnostic Test: Pharmacogenomic testing

Interventions

Pharmacogenomic testing DIAGNOSTIC_TEST

The PGx testing will analyse genetic variants across 16 key pharmacogenes in each given DNA sample, all of which focus on variants with established implications for drug response as recommended by published Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Dutch Pharmacogenetics Working Group (DPWG) guidelines Testing will be performed immediately in the intervention arm or at three months in the standard of care arm.

Intervention; Standard of Care

Eligibility Criteria

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

You may qualify if:

• Capable of giving informed consent directly or via a legal representative (e.g., next of kin, welfare guardian, health care power of attorney).
• Participants who are newly prescribed one of the trial-eligible index drugs during their hospital stay may be approached for consent. Consent should be obtained within 3 days of the first dose of the index drug being administered. If there is a clear clinical plan documented on HEPMA indicating that the patient will be started on an eligible drug (but has not yet received the first dose), consent may be obtained in anticipation. However, formal trial enrolment will only occur once the first dose of the index drug has been administered.
• Participant is able to provide a cheek swab
• Participant is able to take part and be followed-up for at least 12 weeks.
• Participant is resident in NHSGGC health board area OUTPATIENTS
• Age ≥18 years
• Capable of giving informed consent directly or via a legal representative (e.g., next of kin, welfare guardian, health care power of attorney).
• Participants who are expected to be prescribed a trial-eligible drug during their outpatient clinic visit may be approached for consent prior to starting the medication. In these cases, formal trial enrolment will only occur once the patient has confirmed that they have received and started the prescribed medication
• Participant must not have a prescription for this drug in the previous 3 months.
• Participant is able to provide a cheek swab
• Participant is able to take part and be followed-up for at least 12 weeks.
• Participant is resident in NHSGGC health board area.

You may not qualify if:

• Inability to give informed consent directly or via a legal representative.
• Non-English speakers without translation support.
• Participants co-enrolled in other trials where a medication is one of the index drug is part of the trial protocol.
• Inability to give informed consent directly or via a legal representative.
• Non-English speakers without translation support.
• Participants co-enrolled in other trials where a medication is one of the index drug is part of the trial protocol.
• Life expectancy estimated to be less than 6 months by treating clinical team.
• Severe illness limiting participation (investigator discretion).
• Duration of index drug total treatment length is planned to be less than five consecutive days.
• Not registered with a General Practitioner.
• No fixed address.
• Participant is, in the opinion of the Investigator, not suitable to participate in the trial.
• Participant has existing impaired hepatic or renal function for which a lower dose of the index drug or alternate selection of the index drug is already part of current routine care.
• Estimated glomerular filtration rate greater than 15 ml/min/1.73m2 (except for participants with a renal transplant commenced on tacrolimus, who may be included regardless of eGFR, provided they are not on dialysis).eGFR result obtained at screening or within the last 6 months or patients record confirming history of CKD 5
• Participants on any form of dialysis.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (5)

Golden Jubilee National Hospital

Clydebank, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, United Kingdom

RECRUITING

Leverndale Hospital

Glasgow, United Kingdom

RECRUITING

Royal Alexandra Hospital

Glasgow, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (4)

• Swen JJ, van der Wouden CH, Manson LE, Abdullah-Koolmees H, Blagec K, Blagus T, Bohringer S, Cambon-Thomsen A, Cecchin E, Cheung KC, Deneer VH, Dupui M, Ingelman-Sundberg M, Jonsson S, Joefield-Roka C, Just KS, Karlsson MO, Konta L, Koopmann R, Kriek M, Lehr T, Mitropoulou C, Rial-Sebbag E, Rollinson V, Roncato R, Samwald M, Schaeffeler E, Skokou M, Schwab M, Steinberger D, Stingl JC, Tremmel R, Turner RM, van Rhenen MH, Davila Fajardo CL, Dolzan V, Patrinos GP, Pirmohamed M, Sunder-Plassmann G, Toffoli G, Guchelaar HJ; Ubiquitous Pharmacogenomics Consortium. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. Lancet. 2023 Feb 4;401(10374):347-356. doi: 10.1016/S0140-6736(22)01841-4.

  PMID: 36739136 BACKGROUND

• Manson LE, van der Wouden CH, Swen JJ, Guchelaar HJ. The Ubiquitous Pharmacogenomics consortium: making effective treatment optimization accessible to every European citizen. Pharmacogenomics. 2017 Jul;18(11):1041-1045. doi: 10.2217/pgs-2017-0093. Epub 2017 Jul 7. No abstract available.

  PMID: 28685652 BACKGROUND

• Samwald M, Xu H, Blagec K, Empey PE, Malone DC, Ahmed SM, Ryan P, Hofer S, Boyce RD. Incidence of Exposure of Patients in the United States to Multiple Drugs for Which Pharmacogenomic Guidelines Are Available. PLoS One. 2016 Oct 20;11(10):e0164972. doi: 10.1371/journal.pone.0164972. eCollection 2016.

  PMID: 27764192 BACKGROUND

• Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jagel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P, Nolan D, Hughes S, Hughes A, Ryan S, Fitch N, Thorborn D, Benbow A; PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008 Feb 7;358(6):568-79. doi: 10.1056/NEJMoa0706135.

  PMID: 18256392 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Genetic Testing; 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 Officials

• Sandosh Padmanabhan, MD PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine O'Neill

CONTACT

0141 451 6869; elaine.oneill3@nhs.scot

Stefanie Lip, PhD MBChB BSc

CONTACT

stefanie.lip@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 2, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)