Cancer of the Pancreas Screening Study (CAPS 3)
Condition: Pancreatic Neoplasm; Peutz-Jeghers Syndrome
MeSH terms: Pancreatic Neoplasms; Peutz-Jeghers Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to find the best and most sensitive screening modality (CT, MRI,
      EUS)for very small pre-cancerous pancreatic lesions and to treat these small lesions before
      they turn into cancer. Another purpose of this study is to search for common markers on DNA
      that would increase the chance of someone developing pancreatic cancer, and locate proteins
      in pancreatic juice that indicate tumor development.
    

Detailed description: 
      Pancreatic cancer (PC) is the 4th leading cause of cancer death in the U.S. Because it is
      seldom diagnosed at an early curable stage, nearly all patients die from their disease. Early
      detection of PC and its precursors will save lives. In a multi-center, translational
      prospective controlled cohort study, we propose to screen high-risk individuals (members of
      familial pancreatic cancer kindreds and/or those with germline mutations of BRCA-2, p16, or
      STK-11), using EUS, CT, and MRI and test a panel of candidate biomarkers. Patients with
      suspected neoplasms will be offered surgery and the resected pancreata will be examined by an
      expert pathologist. Pathological results will be compared with radiologic findings and
      biomarker results. Our study hypothesis is that screening tests can detect early curable
      non-invasive pancreatic neoplasia in high risk individuals before it progresses to invasive
      cancer. The primary specific aim of this study is to determine the frequency of detectable
      pancreatic neoplasia in individuals with an inherited predisposition for pancreatic cancer.
      Our additional specific aims are: 1) To test the value of a newly-developed method (PANCPRO)
      of calculating the risk families have of developing PC so as to best target who might benefit
      from screening; 2a). To compare performance characteristics and reliability of the pancreatic
      imaging tests EUS, CT, and MRI/MRCP for the detection of early pancreatic neoplasia; 2b) To
      determine the prevalence of abdominal and pelvic tumors by CT and MRI in individuals carrying
      a germ-line BRCA2 gene mutation and patients with Peutz-Jeghers syndrome; 2c) To correlate
      radiologic abnormalities with histologic findings in resected pancreata; and 3). To validate
      a panel of candidate DNA and protein markers (CA19-9, macrophage inhibitory cytokine-1
      (MIC-1), DNA hypermethylation, and KRAS gene mutations) in pancreatic juice and serum as
      indicators of prevalent neoplasms in high risk individuals, compared to concurrently enrolled
      controls.
    

Intervention name(s): Biopsy, Fine Needle Aspiration (FNA); Secretin (human synthetic) - ChiRhoClin
Intervention type(s): Procedure; Drug
Intervention description(s): If a pancreatic lesion of concern is identified, a small needle is inserted in the lesion in the pancreas and cells of the lesion are aspirated. Diagnosis of the lesion can typically occur with FNA.; Secretin is a synthetic human hormone that encourages the pancreas to create fluid. This will allow pancreatic juice to be collected via gentle suction in the duodenum where the pancreatic juice naturally flows.
Other intervention name(s): Human Secretin
Intervention MeSH terms: Secretin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People at risk for developing pancreatic cancer related to a strong family history of
        pancreatic cancer or carries a known genetic mutations associated with pancreatic cancer
      
Biospecimen description: 
      approx 40 ml of blood, approx 10 ml pancreatic juice, pancreatic cells if fine needle
      aspirate is clinically recommended
    
Keywords: pancreatic lesions; pancreatic cancer; peutz-jeghers syndrome; BRCA 2 gene mutation; FAMMM/p16; Genes, BRCA2