NCT06856122

Pharmacogenomics to Improve Supportive Care Symptoms.

Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Palliative Care
• Supportive Care

Timeline

• Start date: 2025-05-09
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2025-03-04
• Last updated: 2025-07-14

Locations

2 sites across 1 country: United Kingdom