MalignancyEpCOTNCT02991105
Epidemiology of Complications After Solid Organ Transplantation - EpCOT Study
An observational study of Malignancy and Transplant Complication, run by University of Birmingham at 2 sites in United Kingdom.
Trial summary
Cancer remains a major cause of morbidity and mortality post solid organ transplantation. While mortality from the other leading causes of death post-transplantation (e.g. cardiovascular disease and infection) is declining, mortality from cancer post-transplantation is increasing (1). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignancy, Transplant Complication, Cancer
- How many people
- 85,410 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 1985to Mar 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 85,410 solid organ transplant have been performed in England between 01/01/1985 and 31/12/2015.
Who may be able to join
- Solid organ transplant recipient, transplant performed in England
Who cannot join
- Transplant performed in Scotland, Wales or Northern Ireland
- Any living transplant recipient who wishes to opt-out of the anonymised record linkage (contact study lead: central contact person)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Birmingham, Edgbaston
Birmingham, West Midlands, B15 2TT
University of Birmingham
Birmingham, B15 2TT
About this study
Cancer remains a major cause of morbidity and mortality post solid organ transplantation. While mortality from the other leading causes of death post-transplantation (e.g. cardiovascular disease and infection) is declining, mortality from cancer post-transplantation is increasing (1). This is due to both general and transplant-specific risk factors that combine to increase risk for cancer compared to the general population. However, there is a shortage of research exploring cancer epidemiology post solid organ transplantation in the UK. This is essential to guide clinicians and for counseling patients regarding expectations and outcomes after developing cancer post-transplantation. This is especially important as the aetiology, pathophysiology and outcomes of cancer post-transplantation may differ from the general population.
Available data registries in the UK separately contain valuable cancer and transplant-specific data that can be combined to explore cancer epidemiology post-transplantation more comprehensively, which can be directly translated into patient benefit by utilizing transplant-specific data (rather than translating from general population or non-UK patient demographics). The purpose of this project is to combine existing data resources to link up the complete patient journey for solid organ transplant recipients and focus on the entire spectrum of cancer from incidence to mortality. In addition, we can use this linked dataset to explore many non-cancer related complications after solid organ transplantation. This will help us better understand the complete burden of disease after transplantation (which may be competing risks for development of cancer) and help improve delivery of effective post-transplant care for UK solid organ transplant patients.
Read the detailed description
Solid organ transplantation is associated with an increased incidence of cancer versus the general population, and broadly on par with comparable immune deficiency states such as HIV/AIDS. The aetiology of cancer post-transplantation is primarily due to the burden of immunosuppression that is compulsory for all transplant patients to prevent allograft rejection. Skewed standardised incidence ratios are observed for cancer post-transplantation compared to the general population, with preponderance for cancers with a strong viral component. The literature on cancer-related mortality after transplantation is scarce, but again disparate mortality risk has been documented comparing solid organ transplant recipients to the general population.
There is a shortage of UK-specific data to guide transplant clinicians on how best to deal with cancer. This is important as countries differ with regards to ethnic demographics and post-transplant immunosuppression protocols, both of which are important confounders to translate data from other transplant cohorts. Collett and colleagues have previously published registry data of cancer incidence in British transplant recipients (by linking UK Transplant Registry to various national cancer registries) for a cohort transplanted between 1980 and 2007. They found similarities but also important differences between cancer incidence in a British solid organ recipient cohort versus registry data from Sweden, Finland, Canada and the United States. Importantly, the relevance of this data to the contemporary solid organ transplant cohort is unclear, as immunosuppression protocols have evolved since 2007 to a predominantly tacrolimus-based regimen since publication of the SYMPHONY study in 2007. No subsequent analysis has been done to determine the impact of tacrolimus introduction into cancer occurrence post-transplantation in the UK.
Our group has previously published the first analysis of cancer-related mortality in the UK, providing data on site of cancer-related mortality and stratifying analysis along demographic factors such as age, gender and/or ethnicity that are relevant to the British population. This analysis linked two different national data resources from the study by Collett and colleagues - Hospital Episode Statistics and the Office for National Statistics. It demonstrated the crude cancer-related mortality rate in England (between 2001 and 2012) was 361 cancer-related deaths per 100,000 person years (compared to 424 and 416 for cardiovascular- and infection-related deaths respectively). Of note, we have also observed cancer-related mortality within the first year post kidney transplantation (7.4%) rises in incidence with increasing time post-transplantation (22.0% beyond the first year post kidney transplantation and second leading cause of death).
Our previous experience has identified the strengths and limitations of utilising such data resources. One of the major limitations with registry data is the absence of important and relevant information that can confound the data, which can be overcome by linking data between registries. For example, in our previous analysis we identified kidney cancer accounted for over half of all cancer-related mortality for kidney transplant recipients with a history of pre-transplant cancer. However, the limitation of our data was we were unable to probe this association further and ascertain a number of important issues; 1) location of kidney cancer (whether native or transplant kidney), 2) whether pre-transplant cancer was kidney-related, and 3) time on dialysis pre-transplant (which is a strong risk factor for acquired cystic renal disease and malignant transformation). While this information was unavailable in our data sets, such information is contained within other national data resources.
Data or record linkage has been defined as "a process of pairing records from two files and trying to select the pairs that belong to the same entity." Cancer data is not routinely collated by transplant centers and there is no robust mechanism to explore cancer epidemiology data post solid organ transplantation through the UK Transplant Registry. However, linking information to other existing data registry resources will facilitate such analysis. This is an under-researched area within both transplant and cancer communities, but increasingly important due to the increasing incidence and prevalence of cancer post solid organ transplantation.
- Conditions
- Malignancy, Transplant Complication, Cancer, Kidney Failure, Liver Failure, Heart Failure
- Keywords
- Malignancy, Cancer, Organ Transplantation
- Medical subject headings
- Neoplasms, Renal Insufficiency, Liver Failure, Heart Failure
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 |
|---|---|---|
| Solid organ transplant recipients | National cohort = 85,410 solid organ transplant recipients receiving their transplant between January 1st 1985 to December 31st 2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related mortality after solid organ transplantation
To compare observed and expected risks of specific causes of deaths, in particular cancer-related death, by linking the UKTR with the national death registry to obtain underlying causes of death and determine factors related to increased risk of specific causes of death post-transplantation. General population mortality rates will be used to calculate expected number of deaths from specific causes and identify subgroups of post-transplant patients (e.g. age, sex, transplant centre, organ type, etc.) at excess risk compared with expected risk.
Investigate survival and causes of death after cancer in post-transplant patients versus individuals from the general population with a similar de novo cancer of the same age, sex, and calendar year of diagnosis.
Measured: 1985-2016 cohort
Secondary outcomes (3)
Risk for cancer after solid organ transplantation
Compare observed and expected risks of specific cancer types post-transplantation by linking the UKTR with the national cancer registry to obtain observed numbers of cancers and determine factors related to increased risk of specific types of cancer. General population cancer incidence rates will be used to calculate expected numbers of cancers of specific type and identify subgroups of post-transplant patients at excess risk of specific cancers compared with expected.
Measured: 1985-2016 cohort
Associated morbidity after developing cancer after solid organ transplantation
Estimate risk of morbidity requiring hospitalisation both generally and that associated with development of post-transplantation cancer by linking the UKTR with Hospital Episode Statistics (HES). Risk of hospital admissions and procedures (e.g. surgery) for specific morbidities will be investigated. We will calculate expected risks for specific conditions requiring hospitalisation, enabling identification of specific subgroups of post-transplant patients at excess risk compared with expected.
Measured: 1985-2016 cohort
Risk prediction for cancer after solid organ transplantation
Machine learning utilising patient level data from linked registries to risk stratify solid organ transplant recipients at risk for cancer
Measured: 1985-2016 cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 1985
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies 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
- Retrospective
- Enrolment
- 85,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Blood and Transplant, NHS England, Public Health England
- Responsible party
- Principal investigator, Adnan Sharif, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991105
- Sponsor's protocol ID
- EpCOT
- Acronym
- EpCOT
- Status last verified
- May 2026
- First submitted
- 1 Dec 2016
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Complications After Solid Organ Transplantation - EpCOT Study
- ClinicalTrials.gov ID
- NCT02991105
- Acronym / sponsor ID
- EpCOT / EpCOT
- Conditions
- Malignancy, Transplant Complication, Cancer, Kidney Failure, Liver Failure, Heart Failure
- Keywords
- Malignancy, Cancer, Organ Transplantation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85,410 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- NHS Blood and Transplant, NHS England, Public Health England
- Study start
- Jan 1985 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Cancer remains a major cause of morbidity and mortality post solid organ transplantation. While mortality from the other leading causes of death post-transplantation (e.g. cardiovascular disease and infection) is declining, mortality from cancer post-transplantation is increasing (1). This is due to both general and transplant-specific risk factors that combine to increase risk for cancer compared to the general population. However, there is a shortage of research exploring cancer epidemiology post solid organ transplantation in the UK. This is essential to guide clinicians and for counseling patients regarding expectations and outcomes after developing cancer post-transplantation. This is especially important as the aetiology, pathophysiology and outcomes of cancer post-transplantation may differ from the general population.
Available data registries in the UK separately contain valuable cancer and transplant-specific data that can be combined to explore cancer epidemiology post-transplantation more comprehensively, which can be directly translated into patient benefit by utilizing transplant-specific data (rather than translating from general population or non-UK patient demographics). The purpose of this project is to combine existing data resources to link up the complete patient journey for solid organ transplant recipients and focus on the entire spectrum of cancer from incidence to mortality. In addition, we can use this linked dataset to explore many non-cancer related complications after solid organ transplantation. This will help us better understand the complete burden of disease after transplantation (which may be competing risks for development of cancer) and help improve delivery of effective post-transplant care for UK solid organ transplant patients.
Detailed description
Solid organ transplantation is associated with an increased incidence of cancer versus the general population, and broadly on par with comparable immune deficiency states such as HIV/AIDS. The aetiology of cancer post-transplantation is primarily due to the burden of immunosuppression that is compulsory for all transplant patients to prevent allograft rejection. Skewed standardised incidence ratios are observed for cancer post-transplantation compared to the general population, with preponderance for cancers with a strong viral component. The literature on cancer-related mortality after transplantation is scarce, but again disparate mortality risk has been documented comparing solid organ transplant recipients to the general population.
There is a shortage of UK-specific data to guide transplant clinicians on how best to deal with cancer. This is important as countries differ with regards to ethnic demographics and post-transplant immunosuppression protocols, both of which are important confounders to translate data from other transplant cohorts. Collett and colleagues have previously published registry data of cancer incidence in British transplant recipients (by linking UK Transplant Registry to various national cancer registries) for a cohort transplanted between 1980 and 2007. They found similarities but also important differences between cancer incidence in a British solid organ recipient cohort versus registry data from Sweden, Finland, Canada and the United States. Importantly, the relevance of this data to the contemporary solid organ transplant cohort is unclear, as immunosuppression protocols have evolved since 2007 to a predominantly tacrolimus-based regimen since publication of the SYMPHONY study in 2007. No subsequent analysis has been done to determine the impact of tacrolimus introduction into cancer occurrence post-transplantation in the UK.
Our group has previously published the first analysis of cancer-related mortality in the UK, providing data on site of cancer-related mortality and stratifying analysis along demographic factors such as age, gender and/or ethnicity that are relevant to the British population. This analysis linked two different national data resources from the study by Collett and colleagues - Hospital Episode Statistics and the Office for National Statistics. It demonstrated the crude cancer-related mortality rate in England (between 2001 and 2012) was 361 cancer-related deaths per 100,000 person years (compared to 424 and 416 for cardiovascular- and infection-related deaths respectively). Of note, we have also observed cancer-related mortality within the first year post kidney transplantation (7.4%) rises in incidence with increasing time post-transplantation (22.0% beyond the first year post kidney transplantation and second leading cause of death).
Our previous experience has identified the strengths and limitations of utilising such data resources. One of the major limitations with registry data is the absence of important and relevant information that can confound the data, which can be overcome by linking data between registries. For example, in our previous analysis we identified kidney cancer accounted for over half of all cancer-related mortality for kidney transplant recipients with a history of pre-transplant cancer. However, the limitation of our data was we were unable to probe this association further and ascertain a number of important issues; 1) location of kidney cancer (whether native or transplant kidney), 2) whether pre-transplant cancer was kidney-related, and 3) time on dialysis pre-transplant (which is a strong risk factor for acquired cystic renal disease and malignant transformation). While this information was unavailable in our data sets, such information is contained within other national data resources.
Data or record linkage has been defined as "a process of pairing records from two files and trying to select the pairs that belong to the same entity." Cancer data is not routinely collated by transplant centers and there is no robust mechanism to explore cancer epidemiology data post solid organ transplantation through the UK Transplant Registry. However, linking information to other existing data registry resources will facilitate such analysis. This is an under-researched area within both transplant and cancer communities, but increasingly important due to the increasing incidence and prevalence of cancer post solid organ transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid organ transplant recipients | – | –National cohort = 85,410 solid organ transplant recipients receiving their transplant between January 1st 1985 to December 31st 2015 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 85,410 solid organ transplant have been performed in England between 01/01/1985 and 31/12/2015.
Key inclusion criteria (1 listed)
- Solid organ transplant recipient, transplant performed in England
Key exclusion criteria (2 listed)
- Transplant performed in Scotland, Wales or Northern Ireland
- Any living transplant recipient who wishes to opt-out of the anonymised record linkage (contact study lead: central contact person)
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
Cancer-related mortality after solid organ transplantation
Time frame: 1985-2016 cohort
To compare observed and expected risks of specific causes of deaths, in particular cancer-related death, by linking the UKTR with the national death registry to obtain underlying causes of death and determine factors related to increased risk of specific causes of death post-transplantation. General population mortality rates will be used to calculate expected number of deaths from specific causes and identify subgroups of post-transplant patients (e.g. age, sex, transplant centre, organ type, etc.) at excess risk compared with expected risk. Investigate survival and causes of death after cancer in post-transplant patients versus individuals from the general population with a similar de novo cancer of the same age, sex, and calendar year of diagnosis.
3 secondary outcomes
Risk for cancer after solid organ transplantation
Time frame: 1985-2016 cohort
Associated morbidity after developing cancer after solid organ transplantation
Time frame: 1985-2016 cohort
Risk prediction for cancer after solid organ transplantation
Time frame: 1985-2016 cohort
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Malignancy and Transplant Complication, run by University of Birmingham 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?
The sponsor lists 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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?
Cancer-related mortality after solid organ transplantation (time frame: 1985-2016 cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.