Pharmacogenomics to Improve Supportive Care Symptoms.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Palliative Care, Supportive Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study
Overview
To understand the clinical utility of multi-gene pharmacogenetic testing in patients receiving palliative and supportive care across palliative care settings (inpatient hospital, outpatient), specifically to calculate a drug-gene interaction ratio, based on extant prescriptions paired with an individual's pharmacogenetic results.
Detailed description
This is a prospective, observational cross-sectional study of patients with serious and/or life limiting condition conditions, such as incurable cancer undergoing palliative or supportive care treatment at a University Teaching Hospital in England, UK. Participants will be recruited at point of referral to in-patient or outpatient palliative care services (i.e. at point of presentation with symptom control issues).
All participant study activities:
All participants will undergo testing of a panel of genetic variants relevant to drugs used in symptom control (see https://cpicpgx.org/genes-drugs/ ). This will involve collecting a 5mL blood sample (the intervention) from individuals. All participants will be consented to examination of their records within local hospitals and/or primary care to extract study relevant data (described below).
The start of follow-up will be from the date of the blood sample (the intervention). Standard demographic information including ethnicity will be collected at baseline.
Participation in study will be for the duration of being under palliative care treatment, up to a maximum of 90days from recruitment date.
All participant sample will be stored and genetic analysis will take place after the end of recruitment and health data collection.
The study team will then calculate a drug-gene interaction ratio (DGI) (i.e. The total number of genetic variation results that pair with a relevant prescribed medication for that same individual, divided by total number of individuals tested).
Primary outcome measures
- Drug-gene interaction ratio (DGI) [Time frame: This will be calculated for all current medications prescribed at the point of recruitment.]
Secondary outcome measures (1)
- Frequency of changes in prescription medication that are potentially affected by drug-gene interaction [Time frame: from enrolment until 90 days post blood test]
Eligibility criteria
Inclusion Criteria: Aged 18 or older; incurable, life limiting condition, clinical care provided at NNUH.
Exclusion Criteria: Lacking capacity to consent to research (unless there is an appropriate consultee)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 2 centers
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich
- The Manchester Centre for Genomic Medicine — Manchester
Publications
- Barry C, Patel M. Pharmacogenomics and symptom management in palliative and supportive care: A scoping review. BMJ Support Palliat Care. 2025 Feb 26;15(2):158-167. doi: 10.1136/spcare-2024-005205. PMID 39805678
- Patel M, McDermott J, Newman W, Barry C. Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study Protocol. NIHR Open Res. 2026 Apr 10;5:125. doi: 10.3310/nihropenres.14182.2. eCollection 2025. PMID 42022754
Identifiers
NCT: NCT06856122 · 2024GRANT089