Active not recruitingNAINTERVENTIONAL

Feasibility of Molecular Biology in Pancreatic Cyst Tumors

This research study is looking into a new way to diagnose growths (cysts) in the pancreas. Doctors currently use scans like MRI and CT, blood tests, and looking at cells from the cyst to figure out what type it is and the best way to treat it. This new study wants to see if analysing the DNA in the fluid taken from inside the cyst can give a more accurate diagnosis. It's a 'multicentre study,' meaning it's happening in several hospitals. The main goal is to find out if this new DNA testing method is accurate and practical to use alongside the usual tests for people with pancreatic cysts.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hospital St. Joseph, Marseille, France

Enrolment target

Start

01 Jan 2017

Estimated completion

01 Jan 2027

Pancreatic Cyst Pancreas Cyst Serous Cystadenoma Mucinous Cystadenoma IPMN

What is this study about?

When doctors suspect someone has a cyst in their pancreas, it's really important to find out what kind of cyst it is. Some cysts are harmless, while others might need treatment or could even become cancerous. Currently, doctors use a combination of tests to get a clear picture. These include imaging scans like MRI and CT to see the cyst's size and features, blood tests to look for certain markers, and sometimes a procedure called EUS-FNA. During an EUS-FNA, a thin needle is guided by a special ultrasound camera into the cyst to collect some fluid and cells for examination. These methods help doctors make a diagnosis and decide on the best treatment plan.

This study is exploring a new technique. It involves looking at the DNA within the fluid collected from inside the pancreatic cyst during the EUS-FNA procedure. The researchers want to compare the information they get from this new DNA test with the information from the standard tests healthcare professionals already use. They're trying to figure out if analysing the DNA can improve how accurately doctors diagnose these cysts.

The main purpose of this study is to see if this DNA analysis is both accurate and practical to use. If it proves to be a better or more precise way to diagnose pancreatic cysts, it could help doctors make more confident decisions about how to manage a patient's care. It’s about trying to improve diagnostic tools to ensure patients get the most appropriate and timely treatment.

Key takeaways

This study evaluates a new DNA test for pancreatic cysts.
It compares the new test to standard diagnostic methods.
The goal is to improve diagnostic accuracy for these cysts.
Participation involves no extra procedures beyond your planned EUS-FNA.
Your immediate medical care will not be affected by joining.
The study aims to benefit future patients by improving diagnosis.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have a cyst in your pancreas that your doctor thinks needs a special procedure called an endoscopic ultrasound with a needle biopsy (EUS-FNA) to help understand what kind of cyst it is and how serious it might be.

However, some things would mean you can't take part. If there's already a lot of uncertainty about what type of pancreatic cyst you have, or if you have certain health conditions that make it unsafe to have the EUS-FNA procedure, you wouldn't be able to join. For example, if you have severe issues with bleeding or blood clotting, or if you're taking certain blood-thinning medications that cannot be stopped, you wouldn't be eligible.

Your doctor will be able to tell you if this study is an option for you based on the specific details of your health and your pancreatic cyst. It's important that the EUS-FNA procedure is considered necessary for your care, regardless 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 old or older?
Do you have a pancreatic cyst?
Has your doctor recommended an EUS-FNA (endoscopic ultrasound with needle biopsy) for your cyst?
Do you have any conditions that would make an EUS-FNA unsafe, like severe bleeding issues?
Are you currently taking certain blood thinners that cannot be stopped?
Is there a clear need to determine the type of your pancreatic cyst?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would undergo the standard endoscopic ultrasound with a needle biopsy (EUS-FNA) procedure that your doctor has already recommended for your pancreatic cyst. During this procedure, a small amount of fluid will be collected from your cyst. This fluid would then be used for the new DNA molecular analysis, in addition to the usual tests already performed on the fluid. There are no extra visits or medications required specifically for this study beyond your planned medical care. The study largely involves using the samples collected during a procedure you would have anyway. The total duration of your participation would mainly depend on the usual follow-up required for your pancreatic cyst and the time it takes for the laboratory analysis.

Potential risks and benefits

Participating in this study will not involve any additional procedures or changes to your treatment beyond what your doctor has already planned. The main benefit is that the information gathered from your sample could help improve how pancreatic cysts are diagnosed in the future, potentially benefiting other patients. However, there are no direct health benefits to you personally from the DNA analysis in this specific study, as the results will be used for research and not to guide your immediate treatment. All medical procedures carry some risks, and your doctor will discuss the potential risks of the EUS-FNA procedure with you, just as they would if you weren't in the study. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (11)

Clinique de Bercy
Verified postcode
Charenton-le-Pont, France
Centre Hospitalier Universitaire Dupuytren
Verified postcode
Limoges, France
Hopital Edouard Herriot
Verified postcode
Lyon, France
Hopital Mermoz
Verified postcode
Lyon, France
Hopital Europeen
Verified postcode
Marseille, France
Hopital Saint Joseph
Verified postcode
Marseille, France
Chu La Timone
Verified postcode
Marseille, France
CHU NANTES Institut des Maladies de l'Appareil Digestif
Verified postcode
Nantes, France
Chu L'Archet 2
Verified postcode
Nice, France
Hopital Saint Joseph
Verified postcode
Paris, France
Centre Hospitalier Jacques Lacarin
Verified postcode
Vichy, France

Common questions

What is a pancreatic cyst?

A pancreatic cyst is a fluid-filled sac that forms in the pancreas, an organ located behind your stomach.

Why is it important to diagnose the type of cyst?

It's important because some cysts are harmless, while others need watching or treatment as they could become serious or cancerous.

Will I get my DNA test results?

The DNA results from this study are for research purposes to compare with current methods and will not be used to guide your immediate treatment.

Will the study change my treatment plan?

No, this study will not change your treatment plan. It aims to see if a new diagnostic method is accurate, not to influence your current care.

Is the EUS-FNA procedure part of the study?

The EUS-FNA procedure is a standard medical test your doctor has already recommended. The study would use a sample collected during this procedure.