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Pharmacogenomics to Improve Supportive Care Symptoms. (PISCES)

N

Norfolk and Norwich University Hospitals NHS Foundation Trust

Status

Invitation-only

Conditions

Supportive Care
Palliative Care

Study type

Observational

Funder types

Other

Identifiers

NCT06856122
2024GRANT089

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

50 participants in 1 patient group

Study participants
Description:
Patients with serious and/or life limiting condition conditions, such as incurable cancer undergoing palliative or supportive care treatment. They will have a 5mL blood sample collected.

Trial contacts and locations

2

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Central trial contact

Dr Martyn Patel; Dr Caroline Barry

Data sourced from clinicaltrials.gov

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