Pancreatic Cancer Collaborative Registry
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Gathering information about patients with cancer may help doctors learn more about
      the disease and plan early diagnosis and treatment.

      PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and
      treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a
      non-cancerous pancreatic disorder.
    

Detailed description: 
      OBJECTIVES:

        -  Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and
           treatment of pancreatic cancer by using the power of computer and informatics sciences.

        -  Continue development of the Pancreatic Cancer Collaborative Registry (PCCR)
           infrastructure to act as a repository for socio-demographic, environmental, clinical,
           and family history data collected from individuals and interested family members with a
           personal and/or family history of pancreatic cancer.

        -  Participate in an international pancreatic registry known as the PCCR by sharing
           information collected for research purposes only, to be used by pancreatic cancer
           research collaborators from other institutions.

        -  Collect and bank excess biological materials (i.e., pancreatic tissue, tumor tissue,
           and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and
           serum from registry participants for future research.

      OUTLINE: This is a multicenter study.

      Patients undergo blood and pancreatic tissue collection. Normal, tumor, and/or metastatic
      pancreatic cancer tissue, and/or paraffin-embedded tissue from prior surgery or biopsy are
      obtained.

      Patients provide or complete personal information about themselves, their medical history,
      their diet and lifestyle habits, any past or current environmental exposures, and re-create
      their family tree for any cancers that have occurred in any of their family members. Clinical
      data is collected annually.

      High Risk participants provide blood samples and complete questionnaires at baseline.
      Clinical data is collected annually.
    

Intervention name(s): medical chart review; questionnaire administration; study of socioeconomic and demographic variables; biopsy
Intervention type(s): Other; Other; Other; Procedure
Intervention description(s): Medical information, called "protected health information" (PHI), which includes demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history will be accessed from the subject's medical record.; Provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, age of death) will be recorded. This information will be collected by whichever method they prefer; completing the questionnaires on hardcopy (to then be entered into the PCCR by a data manager) or by logging on to the PCCR website to complete the questionnaires by obtaining a user id and password to enter their information directly into the PCCR. Study participants who are in the EDRN project are required to complete the questionnaires on hardcopy (to then be entered into the PCCR by a data manager).; Share the information they provided with the PCCR research collaborators. This national group has formed the PCCR and is dedicated to pooling their efforts against pancreatic cancer.; Release a portion of pancreatic tissue, tumor tissue and/or metastatic pancreatic cancer tissue and/or paraffin embedded tissue that has already been collected and saved from their previous surgery or biopsy for storage in the UNMC Solid Tumor Bank for future studies done here or at collaborating institutions. All studies will be proposed in future IRB submissions.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be asked to voluntarily participate in this project because they
        have been diagnosed with PC, have a family history of PC, or fulfill the criteria to be one
        of the three different control groups meaning they will either have a diagnosis of chronic
        pancreatitis, acute biliary obstruction, or they are a healthy unaffected individual.
      
Biospecimen description: 
      Questionnaire Blood: 30ml Access to leftover tissue: release a portion of leftover tissue
      collected and saved from surgery/biopsy.
    
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer