Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06151223

Conditions

Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Bio-specimen Collection: Blood

Bio-specimen Collection: Pancreatic Juice

MRI

Study Details

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.

Conditions

Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Study ID

NCT06151223

Start date

Jul 13, 2021

Status verified date

Mar, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Jul 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Tier 1

  • 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)

Tier 2

  • 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.

Interventions

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.

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.

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.

Primary outcome measure

  • Collection of biospecimen samples (blood and pancreatic juice) [ Time Frame: Up to 10 years ]
  • Collection of radiology images and videos [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Shounak Majumder, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-10.