RecruitingNCT06151223

A Prospective Registry for Patients at High-Risk for Pancreatic Cancer

Sponsor

Mayo Clinic

Enrollment

5,000 participants

Start Date

Jul 13, 2021

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma PDAC PDAC - Pancreatic Ductal Adenocarcinoma

Summary

This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a registry (data collection) study for people who are considered at high risk of developing pancreatic cancer, based on specific medical or genetic criteria. It aims to gather information over time to help researchers better understand how and when pancreatic cancer develops in high-risk individuals, and how best to monitor and catch it early. **You may be eligible if...** - You are 18 years or older - You meet the study's definition of being at high risk for pancreatic cancer (your doctor can determine this based on family history, genetic mutations, or other criteria) - You are willing and able to provide written informed consent **You may NOT be eligible if...** - You have a personal history of pancreatic ductal adenocarcinoma (pancreatic cancer) - You have had your entire pancreas surgically removed (total pancreatectomy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERBio-specimen Collection: Blood

At study enrollment and prior to any pancreatic surgery and prior to or at least 3 days after the most recent GI endoscopy procedure, approximately 50 ml (10 teaspoons) of blood will be drawn from all participants and be processed according to standardized study biospecimen protocol. Serial blood collection will be offered to all the participants depending on the subjects' tier classification. Blood draw will be completed at Mayo Clinic when the subjects come back, or study blood draw kit may be sent for external collection.

OTHERBio-specimen Collection: Pancreatic Juice

This may be collected from research subjects every time they are undergoing a clinically indicated endoscopic ultrasound (EUS), endoscopic retrograde cholangiopancreatography (ERCP) or upper gastrointestinal endoscopy (EGD) procedure. Pancreatic juice will not be collected if PI or provider determines it is not in the best interest of the subject. Pancreatic juice collection will be performed prior to fine needle aspiration (FNA), brushing or stent placements if performed during the same endoscopic procedure.

DIAGNOSTIC_TESTMRI

A research MRI with contrast that includes a Magnetic Resonance Cholangiopancreatography (MRCP) will be offered to patients in the Tier 2 cohort at baseline and at 3-year intervals if not done as standard of care. Gadolinium based intravascular contrast will be administered for this procedure. Sedation for claustrophobia/anxiety per clinical protocol will be an option if the patients requested. Subject would be notified of any concerning results. A safety questionnaire will be completed by the study team before ordering the MRI. Clinically indicated MRIs for the TIER 1 participants will be used and collected as part of the registry. If a clinical MRI/MRCP has been performed between 0 to 3 months before obtaining consent, the prior clinical MRI/MRCP could be used to obtain baseline imaging data.