Pharmacogenomics to Improve Supportive Care Symptoms.

Not yet recruiting

• Conditions: Palliative Care; Supportive Care

• Registration Number: NCT06856122
• Lead Sponsor: 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).

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom

The Manchester Centre for Genomic Medicine; 🇬🇧 Manchester, United Kingdom