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Assessing the Presence of CT-DNA in Lymphoma Associated HLH

This study aims to find a quicker way to diagnose lymphoma in adults who have a life-threatening inflammatory condition called Haemophagocytic Lymphohistiocytosis (HLH). HLH is often caused by lymphoma, a type of blood cancer, but it's hard to diagnose quickly because its symptoms are similar to severe infections. Sadly, many people die because their lymphoma isn't found and treated fast enough. Researchers are investigating if they can detect small amounts of cancer DNA, called ctDNA, in blood samples from patients with HLH. Finding this ctDNA could help doctors diagnose lymphoma earlier, allowing patients to get the right cancer treatment sooner. The goal is to improve the chances of survival for these patients.

At a glance

Status
Recruiting
Sponsor
Nottingham University Hospitals NHS Trust
Enrolment target
12
Start
30 Jun 2023
Estimated completion
01 Jan 2026

What is this study about?

Haemophagocytic Lymphohistiocytosis, or HLH, is a very rare but serious condition that causes widespread inflammation in the body. It can be life-threatening because its symptoms, like fever and feeling very unwell, are similar to severe infections, making it difficult to diagnose early. For adults, the most common cause of HLH is another condition called lymphoma, which is a type of blood cancer.

When someone has HLH caused by lymphoma, it's very important to diagnose the cancer quickly so they can receive the correct treatment. Unfortunately, this can be difficult because the severe inflammation of HLH can make it hard for doctors to carry out the usual tests for cancer, like scans or biopsies. This delay can mean patients don't get the right cancer treatment in time, which can have very serious consequences.

This study is looking into a new and potentially faster way to find lymphoma in patients with HLH. Researchers have found that people with certain types of lymphoma release tiny pieces of DNA from their cancer cells into their blood. This is called 'circulating tumour DNA' or ctDNA. The study will test whether looking for this ctDNA in a simple blood sample can help doctors diagnose lymphoma earlier in people with HLH. If successful, this method could lead to quicker diagnosis and allow patients to start appropriate cancer treatment much sooner, hopefully improving their chances of recovery.

Key takeaways

  • HLH is a serious inflammatory condition often linked to lymphoma in adults.
  • Diagnosing lymphoma quickly is vital for effective treatment.
  • The study explores using cancer DNA (ctDNA) in blood tests for earlier diagnosis.
  • Earlier diagnosis could improve treatment success for HLH patients with lymphoma.
  • Participation involves providing an additional blood sample for analysis.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with HLH. You can take part whether you're newly diagnosed or have had HLH before.

It's important that if you've started certain medical treatments for HLH (like high-dose steroids or cancer-fighting drugs), you would have only started them in the last 72 hours before joining the study. However, if you've been on steroids for longer than two weeks before consenting to the study, that's fine.

You would not be able to join the study if doctors already know that your HLH is definitely caused by something other than cancer.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with HLH?
  3. If you've started high-dose steroids or anti-cancer drugs for HLH, was it within the last 3 days?
  4. Do doctors NOT already know that your HLH is caused by something other than cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you would need to do is provide a small, additional blood sample. This sample would be used to look for the cancer DNA (ctDNA). This is a simple procedure, no different from a standard blood test you might already have as part of your care. There are no extra hospital visits required specifically for the study, nor will you be given any new medications or treatments as part of the research itself. The study aims to look at your blood sample to help understand if this new diagnostic method is effective. Your participation would involve this one blood sample and researchers examining your existing medical information related to your HLH diagnosis.

Potential risks and benefits

For patients taking part, there's no direct personal benefit from being in this study since it's a research study to develop a new diagnostic tool. However, the information gained could greatly benefit future patients with HLH by helping them get an earlier and more accurate diagnosis of lymphoma. The main risk involved is the slight discomfort and small bruise that can sometimes occur with a blood test. You are free to withdraw from the study at any time without giving a reason, and this would not affect your ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Nottingham Univeristy Hospitals NHS Trust
    Verified postcode
    Nottingham, United Kingdom· Recruiting

Common questions

What is HLH?

HLH is a rare, serious condition causing widespread inflammation, often with symptoms like high fever and organ problems. It needs quick diagnosis and treatment.

Why is it important to find lymphoma early in HLH?

Lymphoma is a common cause of HLH in adults. Finding and treating the lymphoma quickly is crucial for improving a patient's chances of survival.

What is 'circulating tumour DNA' (ctDNA)?

CtDNA are tiny fragments of DNA released by cancer cells that can be found in the blood. Researchers are hoping to use these fragments to detect cancer.

Will taking part in this study change my treatment?

No, this is a research study to develop a diagnostic tool. Your treatment will continue to be decided by your medical team based on your condition.

How long does participation last?

Your participation mainly involves providing one additional blood sample. Researchers will then analyse this sample and your medical records related to your HLH.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Assessing the Presence of CT-DNA in Lymphoma Associated HLH…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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