Clinical trial NCT06856122: Pharmacogenomics to Improve Supportive Care Symptoms.
Official title: Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Palliative Care
Supportive Care
Keywords: Pharmacogenomics
pharmacogenetics
palliative
supportive care
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Manchester Centre for Genomic Medicine - St. Mary's Hospital University of Manchester
First posted: 2025-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be from Norfolk and Norwich University Hospitals NHS Foundation Trust

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).

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)

Primary outcomes:
measure: Drug-gene interaction ratio (DGI)
timeFrame: This will be calculated for all current medications prescribed at the point of recruitment.
Secondary outcomes:
measure: Frequency of changes in prescription medication that are potentially affected by drug-gene interaction
timeFrame: from enrolment until 90 days post blood test
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
city: Manchester
country: United Kingdom
facility: The Manchester Centre for Genomic Medicine
Study officials:
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Dr Martyn Patel
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Dr Caroline Barry
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.