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Enrolling by Invitation

NCT Number: NCT06856122

Pharmacogenomics to Improve Supportive Care Symptoms.

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, Norfolk, United Kingdom

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Drug-gene interaction ratio (DGI)

    Time frame: 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 outcomes

  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

    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

Sponsors and collaborators

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Other

Collaborators

  • Manchester Centre for Genomic Medicine - St. Mary's Hospital University of Manchester

Registry information

Official study title

Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study

Acronym: PISCES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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