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Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

Primary Purpose

Extrahepatic Bile Duct Cancer, Pancreatic Cancer

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
proteomic profiling
medical chart review
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Extrahepatic Bile Duct Cancer focused on measuring pancreatic cancer, extrahepatic bile duct cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

  • Serum samples available from participants meeting any of the following criteria:

    • Diagnosis of pancreatic or extrahepatic biliary tract cancer
    • Suspected of having pancreatic or extraheptic biliary tract cancer, including pathologies (e.g., chronic pancreatitis) that might represent pre-neoplastic stages of the malignant disease
    • Healthy control

  • Previously enrolled on the PANKRAS-II study

    • Recruited to study 10 years ago

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Utility of the serum proteome pattern for early detection and diagnosis of pancreatic cancer and extrahepatic biliary tract cancer
    Contact participants (recruited to the PANKRAS-II study 10 years ago) who were diagnosed with benign biliary-pancreatic disease in order to discern if they subsequently developed a malignant biliary-pancreatic tumor
    Gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples by reviewing clinical records of participants

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2007
    Last Updated
    March 7, 2012
    Sponsor
    National Institutes of Health Clinical Center (CC)
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00559598
    Brief Title
    Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer
    Official Title
    Use of Serum Proteome on the Early Diagnosis of Malignant Biliary-Pancreatic Disease
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institutes of Health Clinical Center (CC)
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Studying samples of blood in the laboratory from patients with cancer and from healthy participants may help doctors identify and learn more about proteins related to cancer. It may also help doctors tell whether a patient has cancer. PURPOSE: This clinical trial is looking at proteins in blood samples to see how well they work in finding pancreatic cancer and extrahepatic biliary tract cancer.
    Detailed Description
    OBJECTIVES: To explore the utility of the serum proteome pattern for early detection and diagnosis of pancreatic and extraheptic biliary tract cancer by analyzing serum samples from participants previously enrolled in the PANKRAS-II study. To support efforts to contact participants (recruited to the PANKRAS-II study 10 years ago) who were diagnosed with benign biliary-pancreatic disease in order to discern if they subsequently developed a malignant biliary-pancreatic tumor. To gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples by performing a review of clinical records of participants. OUTLINE: Serum samples are analyzed for proteome pattern. Participants undergo a telephone interview about their medical history (i.e., pancreatic or biliary tract disease diagnosed within the past 10 years). Medical records are reviewed to gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extrahepatic Bile Duct Cancer, Pancreatic Cancer
    Keywords
    pancreatic cancer, extrahepatic bile duct cancer

    7. Study Design

    Enrollment
    502 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    proteomic profiling
    Intervention Type
    Other
    Intervention Name(s)
    medical chart review
    Primary Outcome Measure Information:
    Title
    Utility of the serum proteome pattern for early detection and diagnosis of pancreatic cancer and extrahepatic biliary tract cancer
    Title
    Contact participants (recruited to the PANKRAS-II study 10 years ago) who were diagnosed with benign biliary-pancreatic disease in order to discern if they subsequently developed a malignant biliary-pancreatic tumor
    Title
    Gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples by reviewing clinical records of participants

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Serum samples available from participants meeting any of the following criteria: Diagnosis of pancreatic or extrahepatic biliary tract cancer Suspected of having pancreatic or extraheptic biliary tract cancer, including pathologies (e.g., chronic pancreatitis) that might represent pre-neoplastic stages of the malignant disease Healthy control Previously enrolled on the PANKRAS-II study Recruited to study 10 years ago PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lee E. Moore
    Organizational Affiliation
    NCI - Occupational and Environmental Epidemiology Branch
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

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