Pancreatic Cancer Early Detection Program (PCEDP)

White Plains Hospital

Status: Active, not recruiting

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

Treatments: Procedure: Endoscopic Ultrasound; Procedure: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Other

Identifiers

NCT02206360

WPH 1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 1 patient group

Individuals at elevated risk for pancreatic cancer

Description:

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.

Treatment:

Procedure: Endoscopic Ultrasound

Procedure: Magnetic Resonance Imaging (MRI)