TransplantLines: the Transplantation Biobank

September 2, 2017 updated by: Prof. dr. S.J.L. Bakker, MD, PhD, University Medical Center Groningen
TransplantLines is an observational cohort study in all solid transplant recipients, i.e. kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical capacity. Moreover, we will collect multiple urine and blood samples for analysis. Additionally, we will store hair, nails and faeces from the transplant recipients. Next to this, we will perform physical capacity tests and cognitive tests.

Study Overview

Status

Unknown

Conditions

Detailed Description

The last decades, the acute period after transplantation has markedly improved due to improved tissue-matching techniques and better immunosuppressive drugs. However, nowadays the major aim after transplantation is the long-term patient and graft survival which are still poor, where half of the RTR looses their graft after 10 years. With TransplantLines we are setting up an extensive biobank to improve the long-term survival after transplantation. Moreover, we are one of the few studies to collect across transplant specialities. Like mentioned in the brief summary, extensive questionnaires will be send to participants prior to the visit containing multiple questionnaires (e.g. SF-36, WHODAS, PQ-SGA etc.). During the visit, we will collect multiple blood samples who will be taken during the regularly visit to the clinician. Moreover, two tubes from 24-hour urine collection will be collected, faeces, hair and nails will be stored. Finally, physical tests and cognitive tests will be performed with the participants (e.g. 2-min walking test, 4m walking test, timed-up-and-go test etc.).

Study Type

Observational

Enrollment (Anticipated)

3000

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

  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen

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

All solid organ transplantation patients

Description

Inclusion Criteria:

  • Solid organ transplant recipients

Exclusion Criteria:

  • Age younger than 18 years old
  • Cognitive dysfunction

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
Transplant recipients
Renal, heart, lung, liver, small bowel, pancreas or combined transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft failure / mortality
Time Frame: Untill 2020
Development of graft failure or mortality in the transplant recipients
Untill 2020

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

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

June 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

September 2, 2017

First Submitted That Met QC Criteria

September 2, 2017

First Posted (ACTUAL)

September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • TXLINES01

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.

Clinical Trials on Solid Organ Tranplant Recipients, 18+ Years

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe