RecruitingOBSERVATIONAL

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Doctors often do a special test called a biopsy if a transplanted kidney isn't working as well as it should. This study is testing a new system called the Integrated Diagnostic System. This system uses more than just the usual biopsy results; it also looks at information from advanced tests and other health details. The goal is to get a much more accurate and complete understanding of what might be causing problems with the kidney. By doing this, doctors hope to make better choices about treatment, avoiding treatments that might not help and ensuring patients get the most effective care. This study is looking at many biopsy samples from different hospitals in the UK, Europe, and North America to make sure this new system works well and can be used in everyday patient care.

At a glance

Status

Recruiting

Sponsor

University of Alberta

Enrolment target

500

Start

01 May 2011

Estimated completion

01 Jun 2028

Validation Study of Molecular Diagnostic System Development of Reporting System for Molecular Diagnosis Incorporate Molecular Diagnosis Into Diagnostic Standards

What is this study about?

When someone has a kidney transplant, doctors sometimes need to check if the new kidney is working perfectly or if there are any issues. This usually involves a small procedure called a biopsy, where a tiny piece of the kidney is taken and looked at under a microscope. The way doctors currently interpret these biopsy results is based on a set of agreed-upon guidelines.

However, researchers in this study believe that these current guidelines might not always give the clearest picture, which could sometimes lead to treatments that aren't quite right for the patient. To improve this, they have developed a new system called the 'Integrated Diagnostic System'. This system doesn't just rely on the microscope view of the biopsy. It also uses advanced tests that look at the tiny building blocks of the kidney (molecular features), along with other important information about the patient's health.

The main goal of this study is to test and fine-tune this new system. They are looking at many kidney biopsy samples from patients in different hospitals to make sure the system is accurate and helpful. The hope is that this new approach will give doctors a much more detailed and precise understanding of any problems with a transplanted kidney. This clearer picture should allow doctors to choose the best possible treatment for each patient, improving their care and health.

Key takeaways

This study aims to improve how doctors understand kidney transplant health.
It uses a new 'Integrated Diagnostic System' combining different types of medical information.
No extra tests or procedures are needed if you take part.
The goal is to help doctors make better treatment choices for future patients.
Your medical care will not be affected by your participation.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have had a kidney transplant. Your doctor would need to decide that you need a kidney biopsy for any medical reason, such as checking on the health of your transplanted kidney.

You wouldn't be able to join the study if you prefer not to participate or if you're unable to understand and agree to take part, known as giving informed consent. This study includes both male and female patients of adult age.

Quick self-check

Are you 18 years old or older?
Have you had a kidney transplant?
Does your doctor think you need a kidney biopsy soon?
Are you able to understand and agree to take part in a study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study primarily involves using information from kidney biopsies you would already be having as part of your usual medical care. You wouldn't need to undergo any extra biopsies specifically for the study. Researchers will look at the results from these biopsies, combining them with other medical information. They will also keep track of your health updates over time. You won't have to change any of your current medications or treatments to be part of this study, and there will be no additional clinic visits beyond your usual appointments.

Potential risks and benefits

Participating in this study carries no additional risks to your health, as it uses information from procedures you would already be having. The potential benefits are for future patients, as the insights gained could lead to more accurate diagnoses and better treatment decisions for people with kidney transplants. Your decision to participate or not will not affect your medical care. You are free to withdraw your consent to be part of the study at any time without needing to give a reason.

Locations (26)

University of Alabama
Birmingham, United States· Completed
University of Maryland School of Medicine
Baltimore, United States· Completed
University of Michigan Health System
Ann Arbor, United States· Completed
University of Minnesota
Minneapolis, United States· Completed
Barnes-Jewish Hospital
St Louis, United States· Completed
Montefiore Medical Center
The Bronx, United States· Completed
Pinnacle Transplant Associates
Harrisburg, United States· Completed
Texas Transplant Institute - Methodist Healthcare System
San Antonio, United States· Completed
Virginia Commonwealth University School of Medicine
Richmond, United States· Completed
University of Wisconsin School of Medicine and Public Health
Madison, United States· Completed
Medical University of Vienna
Vienna, Austria· Recruiting
Department of Medicine, University of Alberta
Edmonton, Canada· Recruiting

+14 more sites — see the official record for the full list.

Common questions

What is a microarray?

A microarray is a special test that looks at many tiny pieces of information from your cells at once, helping doctors understand what's happening at a very detailed level.

Will I have to have extra tests or operations?

No, you will not need any extra tests, biopsies, or operations specifically for this study. It uses information from routine procedures you'd be having anyway.

Will this change my current treatment plan?

No, this study is about evaluating a new diagnostic system; it will not directly change your current treatment plan in real-time.

What happens to my personal information?

Your personal information would be handled with strict privacy. The study aims to make sure the system works, not to report on individual patient diagnoses back to you directly.

Who is running this study?

This study is being led by the Alberta Transplant Applied Genomics Centre (ATAGC) with support from many hospitals in the UK, Europe, and North America.

How to find out more

Philip F Halloran, MD PhD

phallora@ualberta.ca 1 780 492-6160 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.