Malignancies in Transplanted Patients

Completed

• Conditions: Neoplasms
• Interventions: Other: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection; Drug: Switch from calcineurin inhibitor to an mTOR inhibitor

• Registration Number: NCT02241564
• Lead Sponsor: Uppsala University

Brief Summary

The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Patients willing and capable of giving written informed consent of participation in the project
• Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma)

Exclusion Criteria

• Patients with a primary liver cancer as cause of the transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malignancy post transplantation	Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection	-
Malignancy post transplantation	Switch from calcineurin inhibitor to an mTOR inhibitor	-

Primary Outcome Measures

Name	Time	Method
Patient survival	12 months, 2 years, 3 years	After inclusion

Secondary Outcome Measures

Name	Time	Method
ImmuKnow Assay value	12 months
Graft survival	12 months, 2 years, 3 years	After inclusion
Tumour progression/regression/reoccurrence	12 months, 2 years, 3 years
Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor	3 years
Kidney function	12 months, 2 years, 3 years	Creatinine measure

Trial Locations

Locations (1)

Department of Surgery, Section of Transplantation Surgery, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden