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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491580
• Other study ID #: PreTXCa
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: July 2, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2370
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Failure
• Neoplasms
• Renal Insufficiency

Locations

Country	Name	City	State
Sweden	Uppsala University, Department of Surgical Sciences, Section of Transplantation Surgery	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Graft survival		Up to 33 years starting in January 1982.	No
Primary	Incidence of post-transplant cancer		Up to 33 years starting in January 1982.	No
Secondary	Patient survival		Up to 33 years starting in January 1982.	No
Secondary	Cancer-induced mortality		Up to 33 years starting in January 1982.	No