Post-transplant Cancer Incidence and Survival in Patients... | NCT02491580

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

NCT02491580

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Jul 8, 2015Estimated

Enrollment

2,370Actual

Phase

Not provided

Conditions

Neoplasms
Kidney Failure

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jun 30, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2015

Last Update Posted Date

Jul 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,370Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KTx Uppsala		Patients who have received a kidney transplant in Uppsala.
KTx Europe		Patients who have received a kidney transplant in Uppsala.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivan Hellström, MD	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University, Department of Surgical Sciences, Section of Transplantation Surgery		Uppsala		SE-751 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27163539	Derived	Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.

ID	Term
D009369	Neoplasms
D051437	Renal Insufficiency

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications