Epidemiology of Complications After Solid Organ Transplantation - EpCOT Study

NCT02991105 | Active Not Recruiting

• 1 other identifier: EpCOT
• Study Type: observational
• Target: 85,410
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Malignancy; Transplant Complication; Cancer; Kidney Failure; Liver Failure; Heart Failure

Keywords

Malignancy; Cancer; Organ Transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  1985-2016 cohort

Secondary Outcomes (3)

• Risk for cancer after solid organ transplantation

  1985-2016 cohort

• Associated morbidity after developing cancer after solid organ transplantation

  1985-2016 cohort

• Risk prediction for cancer after solid organ transplantation

  1985-2016 cohort

Study Arms (1)

Solid organ transplant recipients

National cohort = 85,410 solid organ transplant recipients receiving their transplant between January 1st 1985 to December 31st 2015

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

85,410 solid organ transplant have been performed in England between 01/01/1985 and 31/12/2015.

You may qualify if:

• Solid organ transplant recipient, transplant performed in England

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead
• NHS Blood and Transplant: collaborator
• NHS England: collaborator
• Public Health England: collaborator

Study Sites (2)

University of Birmingham, Edgbaston

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Renal Insufficiency; Liver Failure; Heart Failure

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist & Transplant Physician

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 13, 2016
• Study Start: January 1, 1985
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)