- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06151223
A Prospective Registry for Patients at High-Risk for Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Shounak Majumder, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tier 1
|
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 Names:
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.
Other Names:
|
Tier 2
|
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 Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collection of biospecimen samples (blood and pancreatic juice)
Time Frame: Up to 10 years
|
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
Time Frame: Up to 10 years
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shounak Majumder, M.D., Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-012752
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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