Comparing two methods to follow patients with pancreatic cysts 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 which approach, less frequent or more frequent monitoring, will lead to better outcomes for patients with pancreatic cysts. Why is this study important? Currently, the effectiveness of any pancreatic cyst monitoring strategy is unknown. Patients and physicians are eager to learn which strategy is better for this very common condition. 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 is a risk that the monitoring approach you are assigned to may not be as good as the usual approach in monitoring your cyst(s). 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, you will be randomly placed in one of two groups and you will receive either less frequent monitoring or more frequent monitoring for up to five years. In this study, you will also be asked to complete a few questionnaires at different times, to show how these approaches affect your quality of life and the costs associated with receiving monitoring. 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 Printable information sheet (pdf) Fiche d’information imprimable (pdf) Participating centres Information coming soon.
