RecruitingOBSERVATIONAL

The Detection of Small Early Liver Cancer With Natural History Follow up

The SELINA study is looking for ways to find liver cancer, called hepatocellular carcinoma (HCC), at its very earliest stages. We are studying people who have small HCC, both with and without liver scarring (cirrhosis). By collecting blood, urine, and sometimes liver tissue samples, and performing extra MRI scans on some participants, we hope to discover 'biomarkers'. These are indicators that help us spot cancer earlier. Finding liver cancer sooner could significantly increase a person's chances of successful treatment and survival. The study will help us understand the disease better and develop new detection methods.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

250

Start

23 May 2022

Estimated completion

01 Jun 2035

Hepatocellular Carcinoma

What is this study about?

The SELINA study is all about finding liver cancer, specifically a type called hepatocellular carcinoma (HCC), as early as possible. We know that the sooner cancer is found, the better the chances are for successful treatment and living longer. This study focuses on people who have small HCC, meaning the cancer is still in its very early stages.

We are looking at two main groups of people: those who have HCC along with liver scarring, known as cirrhosis, and those who have HCC but do not have cirrhosis. Cirrhosis can be caused by various liver conditions, and it increases the risk of HCC. By studying both groups, we hope to get a comprehensive understanding of how early liver cancer develops and how we can best spot it.

The main goal is to find 'biomarkers' – these are like clues in your body, such as in blood or urine, that can tell us if early liver cancer is present. We will collect samples and, for some participants, perform detailed MRI scans of the liver. The information we gather will help us develop new and more effective ways to check for liver cancer in the future, ultimately aiming to save more lives.

Key takeaways

Aims to find liver cancer earlier for better survival.
Studies people with early liver cancer, with and without cirrhosis.
Involves blood and urine samples, some will have extra MRI scans.
Hopes to discover new 'biomarkers' for detection.
You are contributing to important future medical knowledge.
You can leave the study at any time.

Who may be eligible?

This study is open to both men and women aged 18 and over who have been diagnosed with small liver cancer (HCC). We're looking for individuals whose HCC is in its early stages (known as BCLC stage 0/A), with small tumours (up to 3 nodules, each less than 3cm in size), and who generally feel well with good liver function. This includes people with small HCC who also have liver scarring (cirrhosis), and those with small HCC who don't have cirrhosis, with the non-cirrhosis diagnosis confirmed by a tissue sample.

You might also be able to join if you had HCC in the past that was successfully treated more than six months ago, and you now have a new, separate diagnosis of HCC in a different part of your liver. Your recent diagnosis of small HCC (within the last three months) is important for joining the study. If you don't have cirrhosis, your diagnosis must be confirmed by a biopsy, not just scans.

However, you won't be able to take part if your liver cancer is more advanced (BCLC stage B/C) or if you've had a liver transplant already (though being on a transplant waiting list is okay). We also can't include you if your HCC has come back in the exact same spot after previous treatment, or if you've had certain cancer treatments in the three months leading up to the study. Lastly, if your doctor feels the study isn't suitable for you or if you can't have an MRI scan (for example, due to claustrophobia or metal in your body), you wouldn't be able to take part in the imaging part of the study.

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 or older?
Do you have a recent diagnosis of small liver cancer?
Have you not had certain liver cancer treatments in the last 3 months?
Are you able to provide blood and urine samples?
If you don't have cirrhosis, was your cancer confirmed by a tissue sample?

Answer every question to see your result.

What does participation involve?

If you decide to join the SELINA study, you will be asked to provide some blood and urine samples. For some participants, if a sample of your liver tissue is already available from previous medical procedures, we might ask to use that for analysis. In a smaller group of people (about 80 participants), we will also ask you to have an extra MRI scan of your liver. These scans are very detailed and help us see your liver closely.

The study involves collecting these samples and potentially having an MRI. There are no study medications involved. We will follow your progress over time, as routinely managed by your doctors. Your participation will help us gather important information for detecting liver cancer. The total length of your participation will depend on how long we need to follow up on your progress, which will be discussed with you in detail.

Potential risks and benefits

Taking part in this study could potentially help advance our understanding of early liver cancer detection, which might lead to better care for future patients. While there are no direct health benefits to you personally from taking part, you'll be contributing to vital medical research. The main risks involve the procedures for collecting blood and urine samples, such as slight discomfort or bruising. For those having an MRI, the risks are minimal but include potential discomfort from lying still or, in rare cases, reactions to contrast dye if used. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hepatology Clinical Trial Unit, John Radcliffe Hospital
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is liver cirrhosis?

Liver cirrhosis is severe scarring of the liver, which can happen after various types of liver damage. It can increase the risk of liver cancer.

What is a 'biomarker'?

A biomarker is a natural signal in your body, like a chemical in your blood or urine, that can give doctors clues about your health or a specific disease, like cancer.

Will I get treatment in this study?

No, this study is focused on detection, not treatment. Your ongoing liver cancer treatment will be managed by your regular medical team.

Is an MRI scan safe?

Yes, MRI scans are generally safe for most people. However, if you have certain metal implants or severe claustrophobia, it might not be suitable for you. We will check this carefully.

How long will I be in the study?

The duration of your participation will be explained in detail by the study team, as it involves follow-up to observe the natural course of your condition.

How to find out more

Clinical Study Coordinator

deliver-selina@ndm.ox.ac.uk Official trial record

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