Epidemiology of Cancer After Solid Organ Transplantation - EpCOT Study (EpCOT)
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|ClinicalTrials.gov Identifier: NCT02991105|
Recruitment Status : Not yet recruiting
First Posted : December 13, 2016
Last Update Posted : October 17, 2017
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. 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 counselling 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 nationally and focus on the entire spectrum of cancer from incidence to mortality. In addition, recruitment of local solid organ transplant recipients will facilitate a more enriched analysis of raw-level data for investigation of screening and management for cancer among solid organ transplant recipients.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||85410 participants|
|Official Title:||Epidemiology of Cancer After Solid Organ Transplantation - EpCOT Study|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||March 2028|
|Estimated Study Completion Date :||March 2028|
Solid organ transplant recipients
National cohort = 85,410 solid organ transplant recipients receiving their transplant between 1985 to 2015
Local cohort = approximately 3,000-4,000 solid organ transplant recipients under secondary care follow up at University Hospitals Birmingham
- Mortality after solid organ transplantation secondary to cancer [ Time Frame: Up to 3-years ]Linked epidemiological dataset for all study participants combining mortality data (from Office for National Statistics) to transplant and cancer-linked data registries to provide causes of death secondary to cancer and non-cancer etiology
- Incidence of cancer after solid organ transplantation [ Time Frame: Up to 3-years ]Analysis of patient level data from linked registries to provide data on cancer incidence after solid organ transplantation
- Associated morbidity after developing cancer after solid organ transplantation [ Time Frame: Up to 3-years ]Analysis of patient level data from linked registries to provide data on associated morbidity after developing cancer after solid organ transplantation
- Risk prediction for cancer after solid organ transplantation [ Time Frame: Up to 3-years ]Machine learning utilising patient level data from linked registries to risk stratify solid organ transplant recipients at risk for cancer
- Management of cancer after solid organ transplantation [ Time Frame: Up to 10-years ]Analysis of primary and secondary care data for recruited patients at solid organ transplant centre
- Screening for cancer after solid organ transplantation [ Time Frame: Up to 10-years ]Analysis of primary and secondary care data for recruited patients at solid organ transplant centre
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991105
|Contact: Adnan Sharif, MD||0121 371 firstname.lastname@example.org|