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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 : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Adnan Sharif, University Hospital Birmingham NHS Foundation Trust

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. 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.


Condition or disease
Malignancy

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Study Type : Observational
Estimated Enrollment : 85410 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiology of Cancer After Solid Organ Transplantation - EpCOT Study
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Risk for cancer after solid organ transplantation [ Time Frame: 1985-2016 cohort ]
    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.

  2. Associated morbidity after developing cancer after solid organ transplantation [ Time Frame: 1985-2016 cohort ]
    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.

  3. Risk prediction for cancer after solid organ transplantation [ Time Frame: 1985-2016 cohort ]
    Machine learning utilising patient level data from linked registries to risk stratify solid organ transplant recipients at risk for cancer



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Solid organ transplant recipient, transplant performed in England

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Adnan Sharif, MD 0121 371 5861 adnan.sharif@uhb.nhs.uk

Locations
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United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2WB
University of Birmingham
Birmingham, United Kingdom, B15 2TT
Contact: Adnan Sharif         
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
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Responsible Party: Adnan Sharif, Consultant Nephrologist, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02991105    
Other Study ID Numbers: EpCOT
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adnan Sharif, University Hospital Birmingham NHS Foundation Trust:
Malignancy
Cancer
Organ Transplantation
Additional relevant MeSH terms:
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Neoplasms