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A pancreatic cyst clinical trial - PAC4

Comparing methods to follow patients with pancreatic cysts and associated biomarkers
Disease Site
Gastro-Intestinal Clinical Trials
Trial Code
PAC.4 ǀ NCT04239573
Trial Status
On Hold

What is the purpose of this study?

The purpose of this study is to determine if looking at blood and images from medical scans can predict which pancreatic cysts will develop into pancreatic cancer.

Why is this study important?

Currently, researchers have not found a good way to predict which pancreatic cysts will progress into cancer, and which ones will not. Researchers are hopeful that medical images and biomarkers, or biological signals found in blood, will be able to help them make these predictions.

Who can participate in this study?

This trial is for adults between the ages of 50 and 75 who have been recently found to have a pancreatic cyst.

This trial is for:

  • Patients who have imaging that confirmed they have 1 or more pancreatic cyst of ≥ 1cm
  • Patients who have a pancreatic cyst that does not require immediate surgery, according to their physician

This trial is not for:

  • Patients with an inflamed pancreas
  • Patients who are pregnant
  • Patients who have any previous pancreatic cancer diagnosis
  • Patients who have a history of pancreatic surgery
  • Patients with pancreatic cysts that are not at risk of being cancer
  • Patients with immediate family members (parents, full siblings and/or children) with a history of pancreatic cancer
  • Patients with a condition that would prevent pancreatic surgery
  • Patients already participating in a form of pancreatic monitoring
What are the risks?
  • If you choose to take part in this study, there are risks associated with the CT, MRI, or EUS medical scans that will be performed. However, these tests will be the same if your pancreatic cyst is monitored with or without your participation in this study. There may also be some risk associated with taking your blood. You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, your pancreatic cyst will be monitored by medical scans for up to 5 years. Your study doctor will determine how often you receive these scans. In addition, blood samples will be collected when you start participating, after 2 years, after 4 years, and if you need to have a biopsy or surgery on your pancreatic cyst. Tissue will be collected if you need to have a biopsy or surgery.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The PAC.4 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT04239573.

https://clinicaltrials.gov/ct2/show/NCT04239573

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.