Pancreatic Cancer Early Detection Program
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Other Indications, Gastrointestinal, Gastrointestinal, Dermatology, Pancreatic Cancer |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2014 |
| End Date: | March 2020 |
| Contact: | Diana Zondorak, CCRC |
| Email: | dzondorak@wphospital.org |
| Phone: | 914-681-2365 |
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
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.
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.
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.
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.
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
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