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Enrolling by invitationNAINTERVENTIONAL

Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy

This study, for people who have had surgery for pancreatic cancer, wants to find out if having regular, planned check-ups can help detect if the cancer comes back earlier. These check-ups would involve blood tests for 'tumour markers' and regular scans. The study is comparing this planned approach to how patients are usually followed up, which varies a lot. Researchers hope that catching any cancer return sooner might lead to better treatment options, helping people live longer and have a better quality of life. The study is particularly interested in how these check-ups affect quality of life. It's an important study because doctors are now finding better ways to treat pancreatic cancer if it does return, making early detection more valuable.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
UMC Utrecht
Enrolment target
306
Start
16 Mar 2021
Estimated completion
01 Oct 2026

What is this study about?

Imagine you’ve had surgery for pancreatic cancer, and the doctors have removed all they could see. That’s great news! However, sometimes, even after successful surgery, the cancer can return, either in the same area or in other parts of the body. Doctors are always looking for the best ways to keep an eye on patients and catch any return of cancer as early as possible.

This study is designed to see if a more organised and standard approach to checking for cancer recurrence, called 'standardised surveillance', can make a difference. This would involve a set schedule of blood tests that look for specific markers that might suggest cancer is present, and regular scans to check for new growths. At the moment, how patients are followed up after pancreatic cancer surgery can be quite different from one hospital to another, or even from one doctor to another. This study wants to compare this new, organised approach with the usual care people receive, by looking at patients who are already part of existing research groups in the Netherlands and the UK.

The main goal is to see if these regular, planned check-ups help people live longer and enjoy a better quality of life. The researchers also want to understand if this standard check-up plan helps doctors find cancer recurrence sooner, makes it easier for patients to get additional treatment if needed, and how well patients tolerate any extra treatments. This is important because new and better treatments for pancreatic cancer are becoming available, and finding the cancer when it’s small might mean these treatments can be more effective.

Key takeaways

  • This study compares a new, organised way of checking for pancreatic cancer recurrence with usual care.
  • It aims to see if having regular blood tests and scans helps people live longer and improves their quality of life.
  • Early detection of cancer returning is becoming more important due to better treatment options.
  • Participation requires being part of specific existing research projects (PACAP or PACOPS).
  • You would either have planned, regular check-ups or continue with your current follow-up.

Who may be eligible?

To be able to take part in this study, you first need to be already involved in one of two specific research projects: the Dutch Pancreatic Cancer Project (PACAP) or the UK Pancreas Cancer: Observations of Practice and survival (PACOPS) study. You would also have given your permission within those studies to be considered for future research like this one. If you're not part of these projects, you won't be able to join this specific study.

Apart from that, the study is for adults over 18 who have had surgery to remove pancreatic cancer, and it must have been confirmed that the cancer was completely (or almost completely) removed. This means the surgeon believes they got all of the visible cancer during the operation.

There are a few reasons why someone might not be able to join. For example, if you have a medical condition that means you cannot safely have a CT scan with contrast dye (a special liquid injected to make scans clearer), you wouldn't be able to participate. Also, if you’re already in another study that involves specific follow-up appointments and tests, you wouldn’t be able to join this one, to avoid any confusion or overlap in your care. Finally, if you are not able to understand or give permission to take part, you cannot participate.

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 already part of the PACAP or PACOPS research study?
  2. Have you had surgery for pancreatic cancer that was fully (or almost fully) removed?
  3. Are you 18 years old or older?
  4. Can you have a CT scan with contrast dye safely?
  5. Are you not currently in another study that involves specific follow-up appointments?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either receive the 'standardised surveillance' plan or continue with the usual follow-up care for pancreatic cancer patients. The 'standardised surveillance' plan would involve regular blood tests to check for specific markers and routine scans to look for any signs of the cancer returning. The frequency of these tests and scans would be set by the study protocol.

Your participation would involve attending these regular appointments for blood tests and scans as scheduled. The study will also be collecting information about your health, how you're feeling, and your quality of life. This data will be gathered over a period of time to track your progress and compare outcomes between the two groups. You wouldn't be taking any new medication specifically for the study itself, but if cancer recurrence is found, your doctors would discuss appropriate treatment options with you based on standard medical care.

Potential risks and benefits

Participating in this study might offer potential benefits, such as the possibility of earlier detection of cancer recurrence if you are in the standardised surveillance group. Catching recurrence sooner could mean more treatment options are available. The potential risks are usually associated with the procedures themselves, like having blood tests (which might cause slight discomfort or bruising) and receiving contrast dye for CT scans (which carries a very small risk of allergic reaction). There’s also the emotional aspect of undergoing regular tests and scans, which can sometimes be worrying. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Radboud University Medical Center
    Verified postcode
    Nijmegen, Netherlands
  • Maastricht UMC
    Verified postcode
    Maastricht, Netherlands
  • Catharina Ziekenhuis
    Verified postcode
    Eindhoven, Netherlands
  • Amsterdam University Medical Center VUmc
    Verified postcode
    Amsterdam, Netherlands
  • Onze Lieve Vrouwe Gasthuis
    Verified postcode
    Amsterdam, Netherlands
  • Amsterdam University Medical Center AMC
    Verified postcode
    Amsterdam, Netherlands
  • Medisch Spectrum Twente
    Verified postcode
    Enschede, Netherlands
  • University Medical Center Groningen
    Verified postcode
    Groningen, Netherlands
  • Sint Antonius Ziekenhuis
    Verified postcode
    Nieuwegein, Netherlands
  • University Medical Center Utrecht
    Verified postcode
    Utrecht, Netherlands
  • University of Birmingham
    Verified postcode
    Birmingham, United Kingdom

Common questions

What does 'standardised surveillance' mean?

It means a specific, planned schedule of check-ups, including blood tests and scans, to look for signs of cancer returning, rather than less frequent or less organised follow-up.

Why is this study important for people with pancreatic cancer?

It's important because new treatments are getting better, and finding cancer recurrence early might help people get these treatments sooner, potentially improving their health and quality of life.

Will I get special treatment if I join this study?

You will either receive the planned, regular check-ups or the usual care. There isn't any new 'experimental' treatment involved, but early detection could lead to existing treatments being used more effectively.

What is 'quality of life' in this study?

Quality of life refers to your overall well-being, including your physical comfort, emotional state, and ability to do daily activities. The study will measure how these are affected.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any point without it affecting the care you receive from your doctors.

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 "Recurrent Disease Detection After Resection of Pancreatic Ad…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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