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Pancreatic Cancer Collaborative Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661882
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Quan Ly, University of Nebraska

Tracking Information
First Submitted Date April 18, 2008
First Posted Date April 21, 2008
Last Update Posted Date May 11, 2017
Study Start Date February 2003
Actual Primary Completion Date September 9, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2017)
Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data [ Time Frame: Yearly ]
Ongoing registry.
Original Primary Outcome Measures
 (submitted: April 18, 2008)
  • Development of integrated Biomedical Computing Tools
  • Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data
  • Participation in the international pancreatic registry known as the PCCR by sharing information
  • Collection and banking of excess biological materials (pancreatic tissue, tumor tissue and/or metastatic pancreatic cancer tissue and/or paraffin-embedded tissue), blood, and serum
  • Establishment of an infrastructure with core data elements and standardized operating procedures for specimen collection, processing, and storage
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pancreatic Cancer Collaborative Registry
Official Title Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry
Brief 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Questionnaire Blood: 30ml Access to leftover tissue: release a portion of leftover tissue collected and saved from surgery/biopsy.
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.
Condition Pancreatic Cancer
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 9, 2017)
379
Original Enrollment
 (submitted: April 18, 2008)
240
Actual Study Completion Date September 9, 2013
Actual Primary Completion Date September 9, 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00661882
Other Study ID Numbers 405-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Request for data and/or specimen will need to be approved by the center's PI.
Responsible Party Quan Ly, University of Nebraska
Study Sponsor Quan Ly
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Quan Ly, MD UNMC Fred and Pamela Buffett Cancer Center
PRS Account University of Nebraska
Verification Date May 2017