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Computer Tools for Improving Early Diagnosis and Treatment in Healthy Volunteers or Patients With Pancreatic Cancer or Who Are At Risk For Pancreatic Cancer or Who Have a Noncancer Pancreatic Disorder
This study is currently recruiting participants.
Verified June 2011 by University of Nebraska

First Received on April 18, 2008.   Last Updated on June 30, 2011   History of Changes
Sponsor: University of Nebraska
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT00661882
  Purpose

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.


Condition Intervention
Pancreatic Cancer
 Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: biopsy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 1) Development of the Pancreatic Cancer Collaborative Registry and Risk Assessment Models; 2) Pancreatic Cancer Pre-Validation Reference Set for Serum/Plasma Biomarkers; 3) Effects of Tobacco and Alcohol on Pancreatic Cancer; 4) Enhancing the Biomedical Computing Platform for Pancreatic Cancer Research

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Pancreatic Diseases
U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Development of integrated Biomedical Computing Tools [ Time Frame: Yearly ] [ Designated as safety issue: No ]
    Ongoing Registry

  • Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data [ Time Frame: Yearly ] [ Designated as safety issue: No ]
    Ongoing registry.

  • Participation in the international pancreatic registry known as the PCCR by sharing information [ Time Frame: Yearly ] [ Designated as safety issue: No ]
    Ongoing registry.

  • Collection and banking of excess biological materials (i.e., pancreatic tissue, tumor tissue ,and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and serum [ Time Frame: Yearly ] [ Designated as safety issue: No ]
    Ongoing registry.

  • Establishment of an infrastructure with core data elements and standardized operating procedures for specimen collection, processing, and storage [ Time Frame: Yearly ] [ Designated as safety issue: No ]
    Ongoing registry.


Estimated Enrollment: 240
Study Start Date: February 2003
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: medical chart review
    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.
    Other: questionnaire administration
    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).
    Other: study of socioeconomic and demographic variables
    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.
    Procedure: biopsy
    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.
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.
  • Establish an infrastructure with core data elements and standardized operating procedures for specimen collection, processing, and storage for the EDRN Pancreatic Cancer Working Group project to use as a resource for the development of biomarkers for the early detection of pancreatic adenocarcinoma.

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.

Control participants provide blood samples and complete questionnaires at baseline. Clinical data is collected annually.

PROJECTED ACCRUAL: A total of 60 patients per group (i.e., cancer cases, healthy controls, acute biliary obstruction cases, and chronic pancreatitis cases) for a total of 240 patients will be accrued for EDRN portion of this study. A total of ~5,000 patients will be accrued to the PCCR portion of this study.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

DISEASE CHARACTERISTICS:

  • Patients must meet 1 of the following criteria:

    • Histologically confirmed adenocarcinoma of the pancreas

      • Resectable stage I-IIA disease or stage IIB or higher disease

        • Must have undergone complete surgical resection of the tumor with curative intent
      • Pancreatic mass (solid) that is less than 4 cm as determined by any conventional imaging (MRI, EUS, or CT scan)
      • No evidence of extension of the mass beyond the pancreas including vascular invasion or invasion into surrounding organs, with the exception of the bile duct
      • No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes greater than 1 cm and/or appearance suspicious for an advanced lesion by imaging criteria)
    • Has a family history of pancreatic cancer and is considered to be an at-risk individual for the disease (i.e., member of a family with 2 or more individuals with pancreatic cancer)

  • Control participants must meet 1 of the following criteria:

    • Chronic pancreatitis OR history of exocrine insufficiency meeting the following criteria:

      • At least 2 of the following criteria are met (unless patient has a history of pancreatic exocrine insufficiency in which case only 1 criterion must be met):

        • Abdominal ultrasound that is consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci in the parenchyma, large or small cavities, calcifications, or dilated pancreatic duct)
        • Abdominal CT scan consistent with chronic pancreatitis by standard radiological criteria (i.e., calcifications, dilated pancreatic duct, irregular contour of the gland, or cystic lesions)
        • Endoscopic retrograde cholangiopancreatography exam consistent with chronic pancreatitis by standard radiological criteria (i.e., dilated tortuous main pancreatic duct with irregular secondary branches or intraductal calculi)
        • Endoscopic ultrasound consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci, focal regions of decreased echogenicity, or pancreatic ductal changes)
        • Pancreatic calcifications identified on plain film of the abdomen
      • Must have an imaging study of the pancreas within 3 months of study enrollment that does not suggest a pancreatic mass
      • Stable clinical history over the past year with no suspicion for cancer due to weight loss, jaundice, or change in abdominal symptoms
      • No family history of pancreatic cancer

    • Acute biliary obstruction (stones) including jaundice of benign etiology meeting the following criteria:

      • Elevation of serum bilirubin level greater than 2.0 mg/dL
      • Dilated extrahepatic biliary systems demonstrated on US, MRI, or CT scan
      • Blood sample available within 72 hours of admission and prior to any corrective intervention
      • Biliary obstruction must be of benign etiology such as common bile duct stone or benign biliary stricture
      • Must have complete imaging study performed of the pancreas that does not suggest a pancreatic cancer (i.e., discrete mass lesion)
      • No family history of pancreatic cancer

    • Healthy control meeting the following criteria:

      • Age, race, and sex-matched to qualified pancreatic cancer cases
      • No family history of pancreatic cancer
      • No personal history of acute pancreatitis or biliary obstruction (stones) including jaundice of benign etiology
      • No concurrent abdominal pain
      • No concurrent unexplained weight loss

PATIENT CHARACTERISTICS:

  • No prior malignancy, except nonmelanoma skin cancer, for 10 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior preoperative chemoradiotherapy (neoadjuvant)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661882

Contacts
Contact: Marsha Ketcham, RN OCN 402-559-5286 mketcham@unmc.edu

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Investigators
Principal Investigator: Simon Sherman, PhD University of Nebraska
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Simon Sherman, Ph.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00661882     History of Changes
Other Study ID Numbers: 405-02, P30CA036727, UNMC-40502
Study First Received: April 18, 2008
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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