Pancreatic Cancer Early Detection Program

Study Overview
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Brief Summary
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Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.

Detailed Description
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Interested individuals can be referred by physicians, or by family or friends. Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk. Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program. We have a weekly review of all calls made and of all enrollments. We have a monthly meeting to review all proceeding regarding the study. Our IRB routinely reviews the proceedings of the study Our institution has a monthly Clinical research Committee meeting.

Official Title
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Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing

Conditions
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Pancreatic Cancer, Pancreas Cancer, HNPCC, Pancreatic Adenocarcinoma, Familial Pancreatic Cancer, BRCA 1/2, Lynch Syndrome, Hereditary Pancreatitis, FAMMM, Familial Atypical Multiple Mole Melanoma, Peutz Jeghers Syndrome

Intervention / Treatment
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* Procedure: Endoscopic Ultrasound
* Procedure: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any of the following: Known carrier of either the BRCA2 or CDKN2A mutation; Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer; Individual with Peutz-Jeghers Syndrome; Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject; Both parents affected, any age: Any first degree relative diagnosed with pancreatic cancer under age 50; Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history Exclusion Criteria: Any medical condition that contraindicates endoscopy or biopsy Any medical condition that contraindicates MRI Status post partial or complete resection of the pancreas History of pancreatic cancer, either endocrine or exocrine Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm). diagnosis of dementia Uncontrolled, current illness Renal insufficiency with serum creatinine greater than 2.0 mg/dl

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals at elevated risk for pancreatic cancer<br>Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. | Procedure: Endoscopic Ultrasound<br> <br> Procedure: Magnetic Resonance Imaging (MRI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing. | Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes which occur as a result of this Protocol | Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing. | 5 years | 
| Complications of any interventions as a result of this Protocol | Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death. | 5 years | 
| Non-Pancreatic cancers diagnosed while on this protocol | Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Pancreatic Cancer, Pancreatic Cancer Screening, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma screening, Familial Pancreatic Cancer, BRCA 1/2, HNPCC, Lynch Syndrome, Hereditary Pancreatitis, FAMMM, Familial atypical multiple mole melanoma, Peutz Jeghers Syndrome, Magnetic Resonance Imaging, EUS, Endoscopic Ultrasound, Early detection, Screening