BRCA 1/2, Familial Atypical Multiple Mole Melanoma, Familial Pancreatic Cancer, FAMMM, Hereditary Pancreatitis, HNPCC, Lynch Syndrome, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Cancer, Peutz Jeghers Syndrome
Conditions
Keywords
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, MRI, Magnetic Resonance Imaging, EUS, Endoscopic Ultrasound, Early detection, Screening
Brief summary
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
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.
Interventions
PROCEDUREEndoscopic Ultrasound
PROCEDUREMagnetic Resonance Imaging (MRI)
Sponsors
White Plains Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any of the following: 1. Known carrier of either the BRCA2 or CDKN2A mutation; 2. 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; 3. Individual with Peutz-Jeghers Syndrome; 4. 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; 5. Both parents affected, any age: 6. Any first degree relative diagnosed with pancreatic cancer under age 50; 7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history
Exclusion criteria
1. Any medical condition that contraindicates endoscopy or biopsy 2. Any medical condition that contraindicates MRI 3. Status post partial or complete resection of the pancreas 4. History of pancreatic cancer, either endocrine or exocrine 5. 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). 6. diagnosis of dementia 7. Uncontrolled, current illness 8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing. | 5 years | Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes which occur as a result of this Protocol | 5 years | Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing. |
| Complications of any interventions as a result of this Protocol | 5 years | Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death. |
| Non-Pancreatic cancers diagnosed while on this protocol | 5 years | Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts. |
Countries
United States
Outcome results
None listed