Clinical trial NCT02206360: Pancreatic Cancer Early Detection Program
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Pancreas Cancer
Pancreatic Adenocarcinoma
Familial Pancreatic Cancer
BRCA 1/2
HNPCC
Lynch Syndrome
Hereditary Pancreatitis
FAMMM
Familial Atypical Multiple Mole Melanoma
Peutz Jeghers Syndrome
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
Lead sponsor: White Plains Hospital
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18 and older, who carry sufficiently elevated risk for the development of pancreatic cancer, numerically defined as over (or near) 5 times the general population risk, as determined by their personal, familial, or genetic history.

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.

Eligibility 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

Primary outcomes:
measure: Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
timeFrame: 5 years
Secondary outcomes:
measure: Clinical outcomes which occur as a result of this Protocol
timeFrame: 5 years
measure: Complications of any interventions as a result of this Protocol
timeFrame: 5 years
measure: Non-Pancreatic cancers diagnosed while on this protocol
timeFrame: 5 years
Other outcomes:
Locations:
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
Study officials:
References: