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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151223
• Other study ID #: 20-012752
• Status: Recruiting
• Start date: July 13, 2021
• Est. completion date: July 2031

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 2031
• Est. primary completion date: July 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• PDAC
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials