mSEPT9 Biomarker for Predicting Hepatocellular Carcinoma Occurrence in Patients With Cirrhosis
This study is investigating a new blood test, called mSEPT9, to see if it can help predict when liver cancer (hepatocellular carcinoma, or HCC) might develop in people who have cirrhosis. Cirrhosis is scarring of the liver, and it can increase the risk of getting liver cancer. Finding liver cancer early is really important for getting the best outcomes. Over 400 people with cirrhosis will take part, giving blood samples every six months for up to five years. Researchers will look at changes in the mSEPT9 levels to see if these changes can give an early warning sign of liver cancer. The aim is to help doctors improve how they watch for liver cancer and offer more personalised care.
At a glance
What is this study about?
This study is looking into a new blood test called mSEPT9. The main goal is to see if this test can help predict whether someone with cirrhosis might develop a type of liver cancer called hepatocellular carcinoma (HCC). Cirrhosis means your liver is scarred, and unfortunately, it often increases the risk of getting liver cancer. Finding liver cancer as early as possible is really important for a person's health and treatment options.
Researchers will follow 400 people who have cirrhosis but don't yet have liver cancer. They will check in with these individuals every six months for up to five years. At each visit, a small blood sample will be taken to measure the mSEPT9 levels. The study wants to find out if changes in these mSEPT9 levels can give an early warning sign that liver cancer might be developing. They'll also look to see if this test works similarly for different causes of cirrhosis, like those caused by different infections or conditions.
The hope is that if this mSEPT9 test proves to be helpful, it could lead to better ways for doctors to keep an eye on people with cirrhosis. This might mean doctors can spot liver cancer earlier than before, potentially leading to earlier treatment and better overall health and quality of life for patients. It's important to remember that during the study, the results of the mSEPT9 test won't directly change your current medical care; they'll be analysed later to understand their predictive power.
Key takeaways
- This study evaluates a new blood test (mSEPT9) for predicting liver cancer.
- It involves people with cirrhosis, who are at higher risk of liver cancer.
- Participation includes regular blood tests every six months for up to five years.
- The aim is to improve early detection and personalised care for liver cancer.
- Test results won't change your current medical care during the study.
- Your routine medical care for cirrhosis will continue as normal.
Who may be eligible?
This study is open to adults aged 18 or older who have been diagnosed with cirrhosis. Your cirrhosis can be due to various reasons, such as alcohol, different types of hepatitis, or other liver conditions. You must be able to regularly attend one of the study centres and be covered by a social security programme.
However, you cannot take part if you have ever had liver cancer or any other major cancer in the last five years. People undergoing kidney dialysis, pregnant or breastfeeding women, or those under legal guardianship are also unable to join. If you have a mental health condition that means you're unable to give consent or follow study instructions, you won't be able to participate either.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of cirrhosis?
- Have you ever had liver cancer or another major cancer in the last 5 years? (You cannot participate if yes)
- Are you pregnant or breastfeeding? (You cannot participate if yes)
- Are you able to attend regular clinic visits for up to 5 years?
What does participation involve?
If you join this study, you won't take any new medication. Your participation will involve attending appointments every six months for up to five years. At each visit, you'll have blood samples taken for the mSEPT9 test, in addition to your usual check-ups, which might include clinical assessments, other blood tests, and scans. These visits will be similar to your routine care for cirrhosis, with the added blood sample collection. The total duration of your involvement could be up to 60 months (5 years).
Potential risks and benefits
Locations (1)
- Regional and University Hospital Center of NancyVerified postcodeVandœuvre-lès-Nancy, France· Recruiting
Common questions
What is cirrhosis?
Cirrhosis is when your liver becomes scarred and damaged, which can affect how well it works. It can be caused by various factors like heavy drinking, certain infections, or other liver conditions.
What is liver cancer (HCC)?
HCC (Hepatocellular Carcinoma) is the most common type of primary liver cancer. It often develops in people who have cirrhosis.
What is the mSEPT9 test?
The mSEPT9 test is a new blood test that researchers hope can help predict the risk of liver cancer developing in people with cirrhosis by looking for specific markers in your blood.
Will my doctors use the mSEPT9 results to treat me?
No, during the study, the results of the mSEPT9 test won't directly affect your current medical care. You'll continue to receive your usual management for cirrhosis.
How often will I need to visit the clinic?
You will need to visit the clinic every six months for up to five years, in addition to your regular appointments, to provide blood samples for the study.
How to find out more
Prof. Abderrahim OUSSALAH, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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