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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 : October 17, 2017
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. 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
Malignancy

  Show Detailed Description

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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 : March 2018
Estimated Primary Completion Date : March 2028
Estimated Study Completion Date : March 2028

Group/Cohort
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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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

NATIONAL COHORT:

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

LOCAL COHORT

All prevalent solid organ transplant recipients (kidney, liver, heart, lung) under follow-up at University Hospitals Birmingham (currently N=3,216) and any incident recipient in the first 2-years of recruitment (2018-2020).

Criteria

NATIONAL COHORT

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)

LOCAL COHORT

Inclusion Criteria:

  • Any solid organ transplant recipient under follow up at University Hospitals Birmingham giving informed consent

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 2000 adnan.sharif@uhb.nhs.uk

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     History of Changes
Other Study ID Numbers: EpCOT
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
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