Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
This study is focused on a new laboratory test, the IdentiClone Dx TRG Assay, which is designed to help diagnose a blood condition called T-cell lymphoproliferative disorder. Researchers want to make sure this new test is accurate. To do this, they will compare its results against an already approved test called the LymphoTrack Dx TRG Assay. They will use DNA samples from people who have already been tested for this condition. The study will look at samples both from people known to have the condition and people suspected of having it but who were diagnosed as negative. This is important to ensure the new test works reliably in different situations.
At a glance
What is this study about?
Imagine your body's immune system as an army protecting you from illness. Sometimes, a specific part of this army, called T-cells, can grow abnormally. When this happens, it's known as a T-cell lymphoproliferative disorder. Doctors need reliable ways to diagnose these conditions accurately.
This study is all about checking how well a new lab test, called the IdentiClone Dx TRG Assay, works. This test looks for specific changes in the DNA of T-cells that can signal the presence of a disorder. To make sure the new test is accurate, researchers will compare its results with those from an established, approved test that does a similar job. Think of it like comparing a new thermometer to one you know is accurate to make sure the new one gives the right temperature.
Researchers will use existing tissue samples, specifically DNA from 'FFPE' samples, which are special tissue blocks often kept after biopsies. They will test samples from people who have been diagnosed with T-cell disorders, as well as samples from people who were suspected of having the condition but were found not to. This helps them understand if the new test is good at both identifying the problem and confirming when it's not there. The goal is to ensure doctors have the best tools to diagnose these conditions correctly.
Key takeaways
- Tests a new diagnostic method for T-cell disorders.
- Uses existing, anonymous tissue samples from previously diagnosed patients.
- Compares the new test to an already approved test for accuracy.
- Aims to improve the reliability of diagnosis for T-cell lymphoproliferative disorders.
- No direct patient involvement or appointments needed.
Who may be eligible?
To be included in this study, the samples must come from adults aged 18 or older. These samples must be existing tissue samples (called 'FFPE specimens') that have been treated in a specific way and have enough material for testing.
The study will look at two main types of samples. Firstly, samples from patients who have already been diagnosed with a T-cell lymphoproliferative disease. This includes various forms of T-cell lymphoma, as well as specific conditions like Mycosis fungoides or Sézary syndrome. Secondly, the study will also include samples from people who were suspected of having a T-cell disorder but were found not to have one. A smaller number of samples from healthy tissue or tissue with other non-T-cell-related diseases may also be included.
If the tissue sample was prepared using different liquids instead of the standard formalin (a type of preserving liquid), it cannot be included in this study. This is to ensure the samples are all processed in a similar way for accurate comparison.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- My doctors suspected or diagnosed me with a T-cell lymphoproliferative disorder.
- My tissue sample was collected when I was 18 years old or older.
- My tissue sample was prepared using standard formalin fixing methods.
- My tissue sample has enough material left for additional testing.
What does participation involve?
If you are reading this, your participation as a living patient is not directly involved because this study uses existing, de-identified tissue samples. This means the researchers will be using leftover tissue (like from a previous biopsy) that has had all personal information removed, so they won't know whose sample it is. You would not need to attend any appointments, take any medication, or have any follow-up visits. Your identity would remain private.
Potential risks and benefits
Locations (3)
- Invivoscribe, Inc.Verified postcodeSan Diego, United States
- LabPMM GmbHVerified postcodeHallbergmoos, Germany
- LabPMM GKCity onlyKawasaki-shi, Japan
Common questions
What is a T-cell lymphoproliferative disorder?
It's a group of conditions where specific immune cells called T-cells grow abnormally in the body.
What is the new test being studied?
It's called the IdentiClone Dx TRG Assay, a lab test designed to help detect specific changes in T-cells.
Why are they doing this study?
To make sure the new test is accurate and works as well as, or better than, existing tests for T-cell disorders.
Will I have to do anything if I enrol?
No, if you're a patient, you won't need to do anything. The study uses anonymous tissue samples that have already been collected.
What are 'FFPE' samples?
These are tissue samples that have been preserved and stored in paraffin wax after being treated with formalin, often after a biopsy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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