Pharmacogenomics to Improve Supportive Care Symptoms.

NCT ID: NCT06856122

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-09

Study Completion Date

2026-10-01

Brief Summary

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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

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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

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Palliative Care Supportive Care

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study participants

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Martyn Patel

Role: PRINCIPAL_INVESTIGATOR

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Dr Caroline Barry

Role: PRINCIPAL_INVESTIGATOR

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Locations

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Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

Site Status

The Manchester Centre for Genomic Medicine

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 39805678 (View on PubMed)

Other Identifiers

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2024GRANT089

Identifier Type: -

Identifier Source: org_study_id

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