Post-transplant Cancer Incidence and Survival in Patients With or Without Pre-transplant Cancer

July 2, 2015 updated by: Uppsala University
Patients with previous malignancies have increasingly been accepted for renal transplantation. However, post-transplant malignancy risk and survival rates of these patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily high risk of post-transplant malignant tumours and if the organs as a resource are too limited for investment in this patient group.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, SE-751 85
        • Uppsala University, Department of Surgical Sciences, Section of Transplantation Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney transplanted patients in Uppsala or Europe with or without a pre-transplant cancer.

Description

Inclusion Criteria:

  • Kidney transplanted patients from January 1982 through December 2013 with or without a pre transplant cancer.

Exclusion Criteria:

  • Simultaneous kidney+pancreas transplantation.
  • Islet cell transplanted patients
  • Undiagnosed malignancies at the time of transplantation
  • Death within a week after transplantation
  • First transplantation at another hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
KTx Uppsala
Patients who have received a kidney transplant in Uppsala.
KTx Europe
Patients who have received a kidney transplant in Uppsala.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of post-transplant cancer
Time Frame: Up to 33 years starting in January 1982.
Up to 33 years starting in January 1982.

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient survival
Time Frame: Up to 33 years starting in January 1982.
Up to 33 years starting in January 1982.
Cancer-induced mortality
Time Frame: Up to 33 years starting in January 1982.
Up to 33 years starting in January 1982.

Other Outcome Measures

Outcome Measure
Time Frame
Graft survival
Time Frame: Up to 33 years starting in January 1982.
Up to 33 years starting in January 1982.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Vivan Hellström, MD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PreTXCa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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