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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
PDAC, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
-----------------
* Other: Bio-specimen Collection: Blood
* Other: Bio-specimen Collection: Pancreatic Juice
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 year Able to provide written informed consent Meets criteria as a High-Risk Individual as defined by protocol Exclusion Criteria: Individual who has a personal history of pancreatic ductal adenocarcinoma (PDAC) History of total pancreatectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tier 1<br>Participants with Peutz-Jeghers syndrome and/or carriers of a germline CDKN2A mutation and/or hereditary pancreatitis with PRSS1 mutation and clinical history of pancreatitis(age ≥40 or 10 years younger than youngest affected blood relative) Carriers of a germline BRCA2, BRCA1, PALB2, ATM, MLH1, MSH2, or MSH6 gene mutation with at least one affected first-degree blood relative (age ≥45 or 10 years younger than youngest affected blood relative) At least one first-degree relative (FDR) with pancreatic cancer who in turn also has a first-degree relative with pancreatic cancer and/or at least two affected blood relatives on the same side of the family, of whom at least one is an FDR to the individual and/or at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual(age ≥50 or 10 years younger than youngest affected blood relative) | Other: Bio-specimen Collection: Blood<br>* 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.<br>* Other names: Blood Draw;Other: Bio-specimen Collection: Pancreatic Juice<br>* 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.<br>* Other names: Pancreatic Juice Collection;|
| Tier 2<br>Individual with family history of PDAC in only one first degree relative (FDR); age ≥50 or 10 years younger than the affected first degree relative OR known BRCA2, BRCA1, PALB2, ATM, MLH1, MSH2, or MSH6 gene mutation; age > 45 who do not meet tier 1 criteria. | Other: Bio-specimen Collection: Blood<br>* 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.<br>* Other names: Blood Draw;Other: Bio-specimen Collection: Pancreatic Juice<br>* 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.<br>* Other names: Pancreatic Juice Collection;Diagnostic Test: MRI<br>* 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.<br>* Other names: Magnetic Resonance Imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of biospecimen samples (blood and pancreatic juice) | Sufficient biospecimens (blood and pancreatic juice) will be collected in 10 years from participants to provide a resource for nested case-control studies of promising biomarkers for discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC).. | Up to 10 years | 
| Collection of radiology images and videos | Collect and archive radiology images and videos obtained during esophagogastroduodenoscopy (EDG)-endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) in high risk individuals undergoing screening and surveillance tests. An imaging dataset designed for studies of promising imaging biomarkers and developing AI-assisted algorithms can be collected within10 years. | Up to 10 years |