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

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

NCT ID: NCT06151223

Condition: Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Bio-specimen Collection: Blood
Description: 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.
Arm group label: Tier 1
Arm group label: Tier 2

Other name: Blood Draw

Intervention type: Other
Intervention name: Bio-specimen Collection: Pancreatic Juice
Description: 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.
Arm group label: Tier 1
Arm group label: Tier 2

Other name: Pancreatic Juice Collection

Intervention type: Diagnostic Test
Intervention name: MRI
Description: 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.
Arm group label: Tier 2

Other name: Magnetic Resonance Imaging

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.

Criteria for eligibility:

Study pop:
Participants at high risk of PDAC will be identified from the providers' calendars, provider referrals, and Mayo Clinic databases.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Shounak Majumder, M.D.
Email: Principal Investigator

Start date: July 13, 2021

Completion date: July 2031

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06151223
https://www.mayo.edu/research/clinical-trials