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

RecruitingOBSERVATIONAL
Enrollment

5,000

Participants

Timeline

Start Date

July 13, 2021

Primary Completion Date

July 31, 2031

Study Completion Date

July 31, 2031

Conditions
Pancreatic CancerPancreatic Ductal AdenocarcinomaPDACPDAC - Pancreatic Ductal Adenocarcinoma
Interventions
OTHER

Bio-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.

OTHER

Bio-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_TEST

MRI

"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."

Trial Locations (1)

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT06151223 - A Prospective Registry for Patients at High-Risk for Pancreatic Cancer | Biotech Hunter | Biotech Hunter