Palliative CarePISCESNCT06856122
Pharmacogenomics to Improve Supportive Care Symptoms.
An observational study of Palliative Care and Supportive Care, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Supportive Care
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 May 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be from Norfolk and Norwich University Hospitals NHS Foundation Trust
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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
The Manchester Centre for Genomic Medicine
Manchester, M13 9WL
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study
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.
Read the 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
- Keywords
- Pharmacogenomics, pharmacogenetics, palliative, supportive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-gene interaction ratio (DGI)
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.
Measured: This will be calculated for all current medications prescribed at the point of recruitment.
Secondary outcomes (1)
Frequency of changes in prescription medication that are potentially affected by drug-gene interaction
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
Measured: from enrolment until 90 days post blood test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start9 May 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester Centre for Genomic Medicine - St. Mary's Hospital University of Manchester
- Responsible party
- Sponsor
- Investigators
- Dr Martyn Patel, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)Dr Caroline Barry, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856122
- Sponsor's protocol ID
- 2024GRANT089
- Acronym
- PISCES
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39805678Patel M, McDermott J, Newman W, Barry C. Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study Protocol. NIHR Open Res. 2026 Apr 10;5:125. doi: 10.3310/nihropenres.14182.2. eCollection 2025.
PubMed 42022754
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06856122
- Acronym / sponsor ID
- PISCES / 2024GRANT089
- Conditions
- Palliative Care, Supportive Care
- Keywords
- Pharmacogenomics, pharmacogenetics, palliative, supportive care
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Manchester Centre for Genomic Medicine - St. Mary's Hospital University of Manchester
- Study start
- 9 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be from Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Frequency of changes in prescription medication that are potentially affected by drug-gene interaction
Time frame: from enrolment until 90 days post blood test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 39805678Barry 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.
- Derived from this study: PubMed 42022754Patel M, McDermott J, Newman W, Barry C. Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study Protocol. NIHR Open Res. 2026 Apr 10;5:125. doi: 10.3310/nihropenres.14182.2. eCollection 2025.
Related trials for Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
Enrolling by invitationPhase 3
Nudging Effective and Equitable Delivery of Specialty Palliative Care
Serious Illness, Palliative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Martyn Patel principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Dr Caroline Barry principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Supportive Care, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-gene interaction ratio (DGI) (time frame: This will be calculated for all current medications prescribed at the point of recruitment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.