Malignancies in Transplanted Patients (MALTX)

October 24, 2017 updated by: Tomas Lorant, Uppsala University

Follow-up of Malignancies in Transplanted Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

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-75185
        • Department of Surgery, Section of Transplantation Surgery, Uppsala University Hospital

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, pancreas or liver transplanted patients in the Uppsala/Örebro region with a diagnosed malignancy pre or post transplantation

Description

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 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
Intervention / Treatment
Malignancy post transplantation
Other: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection
Drug: Switch from calcineurin inhibitor to an mTOR inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: 12 months, 2 years, 3 years
After inclusion
12 months, 2 years, 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

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

November 1, 2007

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MALTX-001

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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