Wrist FracturePERCIPIENTNCT07777081
How the Brain and Body Recover After a Wrist Fracture
An observational study of Wrist Fracture and Complex Regional Pain Syndrome, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
What is the problem? A wrist fracture is a common injury, affecting about 100,000 people in the UK each year. While most people recover well, a significant minority, between 10% and 20%, develop persistent pain and disability that lasts long after the bone has healed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Fracture, Complex Regional Pain Syndrome
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2026to 12 Aug 2032
- 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: Patients with a single wrist fracture Patients with chronic CRPS
Who may be able to join
- Distal radius fracture (DRF) within past 6 weeks 18 and older Willing and competent to complete the informed consent process
Who cannot join
- Inability to understand the informed consent process (Language, competence) Multiple trauma Significant neurological disease (multiple sclerosis, previous traumatic brain injury, previous stroke or cerebral haemorrhage and substantial tremor - including Parkinson's, significant resting tremor, or other aetiology) Amputation or medical confirmation of unilateral sensory deficit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nicholas Shenker, BMBCh PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Neal Chauhan, MBBS, 01223 216182, neal.chauhan@nhs.net
Nicholas Shenker, BMBCh PhD
About this study
Official title: PERCIPIENT - An Evaluation of Pain Biomarkers and Body Representation Outcomes After Distal Radius Fracture
What is the problem? A wrist fracture is a common injury, affecting about 100,000 people in the UK each year. While most people recover well, a significant minority, between 10% and 20%, develop persistent pain and disability that lasts long after the bone has healed. In some cases this leads to a severe chronic pain condition called Complex Regional Pain Syndrome (CRPS). Currently we cannot easily predict who will recover and who may not, making it challenging to provide early targeted support.
What are we trying to find out? We want to see if we can identify "signs" in the body, such as genetic markers, chemical messengers in the blood, and heart rate rhythms, that predict a person's recovery. We are also investigating the brain's "internal map" of the body. After an injury, this map can sometimes become "blurred" or less precise, which we believe is linked to ongoing pain. Our goal is to use this information to help in identify patients at high risk of chronic pain so they could receive better treatment in the future.
Read more
What will happen in the study? We are inviting 250 participants: 200 people with a recent wrist fracture and 50 people who already live with long-term CRPS to act as a comparison group.
All participants will first take part in a baseline assessment. This involves completing questionnaires (including a 0-10 pain rating scale), providing a blood sample, and taking part in simple bedside tests. These tests will also measure your internal body map by checking how accurately you can identify finger touches with your eyes closed and how you compare the size or weight of your limbs.
Based on the results of these objective tests, we will invite some participants with recent wrist fractures to take part in specific sub-studies:
- Brain Scans (24 people): If the bedside tests show changes in your internal map, we will invite you for two fMRI scans, six months apart, to watch the internal map in action whilst performing simple hand tasks.
- Fitness Watches (50 people): Based on your pain rating scores, we will invite 25 people with higher pain and 25 people with lower pain to wear a watch for five days, at the beginning and end of their recovery, to track heart rate rhythms.
- Virtual Reality (20 people): If you still have ongoing pain or a blurred internal map at 6 months, we may invite you to test at-home VR equipment to see if it helps re-train the brain.
Who are we? Our research team includes experts in genetics, brain imaging, pain, and modern digital technologies who have experience in delivering clinical trials.
How will we tell people what we found out?
We are committed to sharing what we learn with the people who make our research possible. We will therefore inform participants and public. Once the study is complete, we will:
- Publish a plain English summary of the results to the public registry ClinicalTrials.gov within 12 months of the study ending
- Provide a direct update to participants who have consented to be contacted for future research via email
- Offer community sharing of our findings through our sponsor Cambridge Arthritis Research Endeavour (CARE) website
- Publish in Academic literature the full scientific results in medical journals to ensure that other doctors and researchers can learn from this study
Read the detailed description
Study Design Prospective cohort Study Participants (1) Patients aged 18 years and older, with an acute fracture of the distal radius within the past 6 weeks, willing and competent to complete the informed consent process. Patients with multiple trauma; have had an open fracture; have a unilateral sensory deficit; significant neurological disease or patients who would be unable to follow trial procedures will be excluded.
(2) Participants with Chronic Complex Regional Pain Syndrome (CRPS), willing and competent to complete the informed consent process.
Planned Size of Sample Total of 250 participants
- 200 with distal radius fractures
- 50 with chronic CRPS Planned Study Period September 2025 - 2029 (4 years) Research Aim The primary aim of this study is to perform multi-domain deep phenotyping of patients following a distal radius fracture, to generate novel hypotheses regarding the biological and physiological mechanisms that predict the transition to chronic pain and Complex Regional Pain Syndrome (CRPS).
Key research questions
- Validate candidate genes and identify molecular biomarkers associated with pain persistence and development of CRPS
- To characterise the neurobiological and bodily representation changes that occur following a wrist fracture and their impact on the patient experience using fMRI
- Investigate autonomic nervous system function as a potential predictor of clinical outcomes using Wearable digital technology
- To assess the feasibility and acceptability of home-based Virtual Reality interventions in body representation disorder and pain persistence patients
Domain level objectives Objectives Outcome measures Time point(s) of evaluation
- Genetic and Molecular biomarkers 1a) Validate candidate genes, previously identified in chronic CRPS cohorts, in a prospective cohort of at-risk patients' post-fracture Frequency of four specific CRPS associated SNPs determined through PCR analysis PCR analysis of genomic DNA extracted from participants whole blood at month 0 n. 200 (DRF patients) 1b) To analyse for molecular biomarkers that may link with development of chronic pain and CRPS Biomarkers (including cytokines TNFα, Il-1 and IL-6, miRNA expression profiles miR-232 and miR-939 and autoantibodies) Biomarker analysis from whole blood samples taken at month 0 for all DRF patients and at month 6 for participants enrolled in sub-studies Month 0 n. 200 (DRF patients) Month 6 n. 50 - 94 (Sub-studies follow up participants) 1c) To compare genetic and molecular biomarker profiles from acute fracture cohort with those from an established chronic CRPS patient cohort Biomarkers (including cytokines TNFα, Il-1 and IL-6, miRNA expression profiles miR-232 and miR-939 and autoantibodies) Biomarker analysis from whole blood samples taken at month 0 n. 50 (chronic CRPS)
- Neurobiology and Body Representation Disturbance (BRD)
2a) To identify predictive neural signatures in hypothesis-driven regions of interest (e.g. insula, parietal cingulate and ventral premotor cortices) Functional MRI Functional connectivity measures and Brain activation patters measured as Blood-Oxygen-Level-Dependent (BOLD) fMRI performed at month 0 and 6 n. 24 DRF
- 2:1 ratio between disturbed and normal body representation (16 BRD Vs 6 non-BRD 2b) To quantify the impact of BRD on pain severity, perception and quality of life in participants following a distal radius fracture Patient reported outcome measures (PROMS)
- Bath CRPS Body Perception Disturbance Scale
- Neglect-Like Questionnaire
- Body disownership scale
- Brief Pain Inventory
- Fear of Pain Questionnaire - Short form
- Pain Catastrophizing Scale
- Pain Self Efficacy Questionnaire
- Quick Disabilities of the Arm, Shoulder and Hand
- Pittsburgh Sleep Quality Index
- Edinburgh Handedness Index - Short Form
- Hospital Anxiety and Depression Scale PROMS performed at month 0 for all DRF patients and at month 6 for participants enrolled in sub-studies Month 0 n. 200 (DRF) Month 6 n. 50 - 94 (Sub-studies follow up participants) 3. Heart rate variability (wearable digital technology) 3a) To analyse heart rate variability captured via remote wearable technology as a biomarker for predicting outcomes in baseline high vs low pain groups and recovery between high and low pain scores (VAS >6 and <3 respectively) Heart rate variability obtained from wearable device worn on non-fractured wrist for 5 days. Months 0 and 6 n. 50
- 1:1 ratio between numerical rating scale <3 and >6 (25 <3 Vs 25 >6) 4. Virtual Reality intervention feasibility 4a) To evaluate the feasibility, acceptability and preliminary influence on pain and body representation of a home-based virtual reality intervention. Self-reported feasibility and subjectivity questionnaire outcomes and digital wearable variables over 7-day regular usage period.
Patient reported outcome measures (PROMS)
- Tampa Scale of Kinesiophobia
- System Usability Scale
- Virtual Reality Subjective Questionnaire
- Subjective Experience Survey Month 6 n. 20 (BRD or pain persistence at 6 months)
- Conditions
- Wrist Fracture, Complex Regional Pain Syndrome
- Keywords
- Chronic pain, Body representation, post- wrist fracture, functional MRI, Genes
- Medical subject headings
- Wrist Fractures, Complex Regional Pain Syndromes, Chronic Pain
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 |
|---|---|---|
| Post-wrist fracture | Blood sample for genetic analysis and other blood biomarkers | |
| Post-wrist fracture with and without body scheme disruption | For functional MRI scanning in participants with and without body scheme disruption | |
| Patients with chronic CRPS | Blood sample for genetic analysis and other blood biomarkers | |
| Patients with chronic CRPS with body scheme disruption | For functional MRI scanning in participants with CRPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rare SNPs in genetic analysis
A whole blood sample will be collected from each participant at baseline. DNA will be analysis to identify the presence or absence of pre-specified candidate Single Nucleotide Polymorphisms (SNP) alleles, previously associated with chronic CRPS, via Polymerase Chain Reaction (PCR). Participants will then be categorised as variant positive or negative.
Measured: 5 years
Secondary outcomes (1)
Functional MRI biomarkers
Structural and functional MRI scans will be performed at month 0 and 6 using 3T MRI facilities at the Wolfson Brain Imaging Centre in Cambridge. This will involve a 1-hour scanning time, including stuctural (T1-weighted and Diffusion Tensor Imaging (DTI)) and functional (task-based and resting-state BOLD) fMRI.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start12 Aug 2026
- Primary completion12 Aug 2031 (estimated)
- Study completion12 Aug 2032 (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 Wrist FractureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Anglia Ruskin University
- Responsible party
- Principal investigator, Dr Nicholas Shenker, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777081
- Sponsor's protocol ID
- A097327
- Acronym
- PERCIPIENT
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may not be in an appropriate format to be shared
Publications
Shaikh SS, Goebel A, Lee MC, Nahorski MS, Shenker N, Pamela Y, Drissi I, Brown C, Ison G, Shaikh MF, Kuttikat A, Woods WA, Dixit A, Stouffer K, Clarke MC, Menon DK, Woods CG. Evidence of a genetic background predisposing to complex regional pain syndrome type 1. J Med Genet. 2024 Jan 19;61(2):163-170. doi: 10.1136/jmg-2023-109236.
PubMed 37816627Moseley GL, Herbert RD, Parsons T, Lucas S, Van Hilten JJ, Marinus J. Intense pain soon after wrist fracture strongly predicts who will develop complex regional pain syndrome: prospective cohort study. J Pain. 2014 Jan;15(1):16-23. doi: 10.1016/j.jpain.2013.08.009. Epub 2013 Nov 19.
PubMed 24268113
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERCIPIENT - An Evaluation of Pain Biomarkers and Body Representation Outcomes After Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT07777081
- Acronym / sponsor ID
- PERCIPIENT / A097327
- Conditions
- Wrist Fracture, Complex Regional Pain Syndrome
- Keywords
- Chronic pain, Body representation, post- wrist fracture, functional MRI, Genes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, Anglia Ruskin University
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 12 Aug 2031 (estimated)
- Study completion
- 12 Aug 2032 (estimated)
- First posted
- 20 Aug 2026 (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.
What is the problem? A wrist fracture is a common injury, affecting about 100,000 people in the UK each year. While most people recover well, a significant minority, between 10% and 20%, develop persistent pain and disability that lasts long after the bone has healed. In some cases this leads to a severe chronic pain condition called Complex Regional Pain Syndrome (CRPS). Currently we cannot easily predict who will recover and who may not, making it challenging to provide early targeted support.
What are we trying to find out? We want to see if we can identify "signs" in the body, such as genetic markers, chemical messengers in the blood, and heart rate rhythms, that predict a person's recovery. We are also investigating the brain's "internal map" of the body. After an injury, this map can sometimes become "blurred" or less precise, which we believe is linked to ongoing pain. Our goal is to use this information to help in identify patients at high risk of chronic pain so they could receive better treatment in the future.
What will happen in the study? We are inviting 250 participants: 200 people with a recent wrist fracture and 50 people who already live with long-term CRPS to act as a comparison group.
All participants will first take part in a baseline assessment. This involves completing questionnaires (including a 0-10 pain rating scale), providing a blood sample, and taking part in simple bedside tests. These tests will also measure your internal body map by checking how accurately you can identify finger touches with your eyes closed and how you compare the size or weight of your limbs.
Based on the results of these objective tests, we will invite some participants with recent wrist fractures to take part in specific sub-studies:
- Brain Scans (24 people): If the bedside tests show changes in your internal map, we will invite you for two fMRI scans, six months apart, to watch the internal map in action whilst performing simple hand tasks.
- Fitness Watches (50 people): Based on your pain rating scores, we will invite 25 people with higher pain and 25 people with lower pain to wear a watch for five days, at the beginning and end of their recovery, to track heart rate rhythms.
- Virtual Reality (20 people): If you still have ongoing pain or a blurred internal map at 6 months, we may invite you to test at-home VR equipment to see if it helps re-train the brain.
Who are we? Our research team includes experts in genetics, brain imaging, pain, and modern digital technologies who have experience in delivering clinical trials.
How will we tell people what we found out?
We are committed to sharing what we learn with the people who make our research possible. We will therefore inform participants and public. Once the study is complete, we will:
- Publish a plain English summary of the results to the public registry ClinicalTrials.gov within 12 months of the study ending
- Provide a direct update to participants who have consented to be contacted for future research via email
- Offer community sharing of our findings through our sponsor Cambridge Arthritis Research Endeavour (CARE) website
- Publish in Academic literature the full scientific results in medical journals to ensure that other doctors and researchers can learn from this study
Detailed description
Study Design Prospective cohort Study Participants (1) Patients aged 18 years and older, with an acute fracture of the distal radius within the past 6 weeks, willing and competent to complete the informed consent process. Patients with multiple trauma; have had an open fracture; have a unilateral sensory deficit; significant neurological disease or patients who would be unable to follow trial procedures will be excluded.
(2) Participants with Chronic Complex Regional Pain Syndrome (CRPS), willing and competent to complete the informed consent process.
Planned Size of Sample Total of 250 participants
- 200 with distal radius fractures
- 50 with chronic CRPS Planned Study Period September 2025 - 2029 (4 years) Research Aim The primary aim of this study is to perform multi-domain deep phenotyping of patients following a distal radius fracture, to generate novel hypotheses regarding the biological and physiological mechanisms that predict the transition to chronic pain and Complex Regional Pain Syndrome (CRPS).
Key research questions
- Validate candidate genes and identify molecular biomarkers associated with pain persistence and development of CRPS
- To characterise the neurobiological and bodily representation changes that occur following a wrist fracture and their impact on the patient experience using fMRI
- Investigate autonomic nervous system function as a potential predictor of clinical outcomes using Wearable digital technology
- To assess the feasibility and acceptability of home-based Virtual Reality interventions in body representation disorder and pain persistence patients
Domain level objectives Objectives Outcome measures Time point(s) of evaluation
- Genetic and Molecular biomarkers 1a) Validate candidate genes, previously identified in chronic CRPS cohorts, in a prospective cohort of at-risk patients' post-fracture Frequency of four specific CRPS associated SNPs determined through PCR analysis PCR analysis of genomic DNA extracted from participants whole blood at month 0 n. 200 (DRF patients) 1b) To analyse for molecular biomarkers that may link with development of chronic pain and CRPS Biomarkers (including cytokines TNFα, Il-1 and IL-6, miRNA expression profiles miR-232 and miR-939 and autoantibodies) Biomarker analysis from whole blood samples taken at month 0 for all DRF patients and at month 6 for participants enrolled in sub-studies Month 0 n. 200 (DRF patients) Month 6 n. 50 - 94 (Sub-studies follow up participants) 1c) To compare genetic and molecular biomarker profiles from acute fracture cohort with those from an established chronic CRPS patient cohort Biomarkers (including cytokines TNFα, Il-1 and IL-6, miRNA expression profiles miR-232 and miR-939 and autoantibodies) Biomarker analysis from whole blood samples taken at month 0 n. 50 (chronic CRPS)
- Neurobiology and Body Representation Disturbance (BRD)
2a) To identify predictive neural signatures in hypothesis-driven regions of interest (e.g. insula, parietal cingulate and ventral premotor cortices) Functional MRI Functional connectivity measures and Brain activation patters measured as Blood-Oxygen-Level-Dependent (BOLD) fMRI performed at month 0 and 6 n. 24 DRF
- 2:1 ratio between disturbed and normal body representation (16 BRD Vs 6 non-BRD 2b) To quantify the impact of BRD on pain severity, perception and quality of life in participants following a distal radius fracture Patient reported outcome measures (PROMS)
- Bath CRPS Body Perception Disturbance Scale
- Neglect-Like Questionnaire
- Body disownership scale
- Brief Pain Inventory
- Fear of Pain Questionnaire - Short form
- Pain Catastrophizing Scale
- Pain Self Efficacy Questionnaire
- Quick Disabilities of the Arm, Shoulder and Hand
- Pittsburgh Sleep Quality Index
- Edinburgh Handedness Index - Short Form
- Hospital Anxiety and Depression Scale PROMS performed at month 0 for all DRF patients and at month 6 for participants enrolled in sub-studies Month 0 n. 200 (DRF) Month 6 n. 50 - 94 (Sub-studies follow up participants) 3. Heart rate variability (wearable digital technology) 3a) To analyse heart rate variability captured via remote wearable technology as a biomarker for predicting outcomes in baseline high vs low pain groups and recovery between high and low pain scores (VAS >6 and <3 respectively) Heart rate variability obtained from wearable device worn on non-fractured wrist for 5 days. Months 0 and 6 n. 50
- 1:1 ratio between numerical rating scale <3 and >6 (25 <3 Vs 25 >6) 4. Virtual Reality intervention feasibility 4a) To evaluate the feasibility, acceptability and preliminary influence on pain and body representation of a home-based virtual reality intervention. Self-reported feasibility and subjectivity questionnaire outcomes and digital wearable variables over 7-day regular usage period.
Patient reported outcome measures (PROMS)
- Tampa Scale of Kinesiophobia
- System Usability Scale
- Virtual Reality Subjective Questionnaire
- Subjective Experience Survey Month 6 n. 20 (BRD or pain persistence at 6 months)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Post-wrist fracture | – | –Blood sample for genetic analysis and other blood biomarkers |
| Post-wrist fracture with and without body scheme disruption | – | –For functional MRI scanning in participants with and without body scheme disruption |
| Patients with chronic CRPS | – | –Blood sample for genetic analysis and other blood biomarkers |
| Patients with chronic CRPS with body scheme disruption | – | –For functional MRI scanning in participants with CRPS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a single wrist fracture Patients with chronic CRPS
Key inclusion criteria (1 listed)
- Distal radius fracture (DRF) within past 6 weeks 18 and older Willing and competent to complete the informed consent process
Key exclusion criteria (1 listed)
- Inability to understand the informed consent process (Language, competence) Multiple trauma Significant neurological disease (multiple sclerosis, previous traumatic brain injury, previous stroke or cerebral haemorrhage and substantial tremor - including Parkinson's, significant resting tremor, or other aetiology) Amputation or medical confirmation of unilateral sensory deficit
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
Rare SNPs in genetic analysis
Time frame: 5 years
A whole blood sample will be collected from each participant at baseline. DNA will be analysis to identify the presence or absence of pre-specified candidate Single Nucleotide Polymorphisms (SNP) alleles, previously associated with chronic CRPS, via Polymerase Chain Reaction (PCR). Participants will then be categorised as variant positive or negative.
1 secondary outcome
Functional MRI biomarkers
Time frame: 5 years
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 20 Aug 2026.
- Background: PubMed 37816627Shaikh SS, Goebel A, Lee MC, Nahorski MS, Shenker N, Pamela Y, Drissi I, Brown C, Ison G, Shaikh MF, Kuttikat A, Woods WA, Dixit A, Stouffer K, Clarke MC, Menon DK, Woods CG. Evidence of a genetic background predisposing to complex regional pain syndrome type 1. J Med Genet. 2024 Jan 19;61(2):163-170. doi: 10.1136/jmg-2023-109236.
- Background: PubMed 24268113Moseley GL, Herbert RD, Parsons T, Lucas S, Van Hilten JJ, Marinus J. Intense pain soon after wrist fracture strongly predicts who will develop complex regional pain syndrome: prospective cohort study. J Pain. 2014 Jan;15(1):16-23. doi: 10.1016/j.jpain.2013.08.009. Epub 2013 Nov 19.
- CRPS UK NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data may not be in an appropriate format to be shared
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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.
Nicholas Shenker, BMBCh PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Fracture and Complex Regional Pain Syndrome, run by Cambridge University Hospitals NHS Foundation Trust at 1 site 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Neal Chauhan, MBBS (01223 216182, neal.chauhan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rare SNPs in genetic analysis (time frame: 5 years). 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 NCT07777081, 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 20 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.