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.
Brief Title
Pancreatic Cancer Early Detection Program
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
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
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
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
Inclusion 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
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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02206360
Org Class
Other
Org Full Name
White Plains Hospital
Org Study Id
WPH 1401
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
Outcome Measure
Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
Outcome Time Frame
5 years
Secondary Outcomes
Outcome Description
Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.
Outcome Time Frame
5 years
Outcome Measure
Clinical outcomes which occur as a result of this Protocol
Outcome Description
Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.
Outcome Time Frame
5 years
Outcome Measure
Complications of any interventions as a result of this Protocol
Outcome Description
Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.
Outcome Time Frame
5 years
Outcome Measure
Non-Pancreatic cancers diagnosed while on this protocol
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joshua Raff
Investigator Email
jraff@wphospital.org
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Prostate Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- COLORECTAL NEOPLASMS
Gastrointestinal (GI) Cancers --- INTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
Diabetes --- METABOLIC DISEASES
Diabetes & Endocrine System --- METABOLIC DISEASES
Blood & Bone Marrow Cancers --- NEOPLASMS BY HISTOLOGIC TYPE
MeSH Terms
PANCREATIC NEOPLASMS
PANCREATIC CARCINOMA, FAMILIAL
COLORECTAL NEOPLASMS, HEREDITARY NONPOLYPOSIS
HEREDITARY PANCREATITIS
DYSPLASTIC NEVUS SYNDROME
PEUTZ-JEGHERS SYNDROME
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
ENDOCRINE GLAND NEOPLASMS
DIGESTIVE SYSTEM DISEASES
PANCREATIC DISEASES
ENDOCRINE SYSTEM DISEASES
COLORECTAL NEOPLASMS
INTESTINAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
NEOPLASTIC SYNDROMES, HEREDITARY
GASTROINTESTINAL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
GENETIC DISEASES, INBORN
CONGENITAL, HEREDITARY, AND NEONATAL DISEASES AND ABNORMALITIES
DNA REPAIR-DEFICIENCY DISORDERS
METABOLIC DISEASES
NUTRITIONAL AND METABOLIC DISEASES
NEVUS
NEVI AND MELANOMAS
NEOPLASMS BY HISTOLOGIC TYPE
INTESTINAL POLYPOSIS
LENTIGO
MELANOSIS
HYPERPIGMENTATION
PIGMENTATION DISORDERS
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION
MAGNETIC RESONANCE SPECTROSCOPY
BIOPSY, FINE-NEEDLE
BIOPSY, NEEDLE
BIOPSY
CYTODIAGNOSIS
CYTOLOGICAL TECHNIQUES
CLINICAL LABORATORY TECHNIQUES
DIAGNOSTIC TECHNIQUES AND PROCEDURES
DIAGNOSIS
IMAGE-GUIDED BIOPSY
SPECIMEN HANDLING
ULTRASONOGRAPHY, INTERVENTIONAL
ULTRASONOGRAPHY
DIAGNOSTIC IMAGING
DIAGNOSTIC TECHNIQUES, SURGICAL
SURGICAL PROCEDURES, OPERATIVE
MINIMALLY INVASIVE SURGICAL PROCEDURES
INVESTIGATIVE TECHNIQUES
SPECTRUM ANALYSIS
CHEMISTRY TECHNIQUES, ANALYTICAL