Pharmacogenomics to Improve Supportive Care Symptoms. (PISCES)
Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M13 9WL
- The Manchester Centre for Genomic Medicine
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Norfolk
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Norwich, Norfolk, United Kingdom, NR4 7UY
- Norfolk and Norwich University Hospitals Nhs Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Drug-gene interaction ratio (DGI)
Time Frame: This will be calculated for all current medications prescribed at the point of recruitment.
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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.
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This will be calculated for all current medications prescribed at the point of recruitment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequency of changes in prescription medication that are potentially affected by drug-gene interaction
Time Frame: from enrolment until 90 days post blood test
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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
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from enrolment until 90 days post blood test
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Collaborators and Investigators
Investigators
- Principal Investigator: Dr Martyn Patel, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Principal Investigator: Dr Caroline Barry, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024GRANT089
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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