Palliative Care, Supportive Care
Conditions
Keywords
Pharmacogenomics, pharmacogenetics, palliative, supportive care
Brief summary
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).
Interventions
None listed
Sponsors
Manchester Centre for Genomic Medicine - St. Mary's Hospital University of Manchester
Norfolk and Norwich University Hospitals NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug-gene interaction ratio (DGI) | This will be calculated for all current medications prescribed at the point of recruitment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of changes in prescription medication that are potentially affected by drug-gene interaction | from enrolment until 90 days post blood test | Number of participants who have a change in prescribed medication (dose or formulation) during 90 day follow up period that could be theoretically paired to possession of a clinically relevant drug-gene interaction |
Countries
United Kingdom
Outcome results
None listed