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Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

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ClinicalTrials.gov Identifier: NCT00559598
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : March 8, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date November 15, 2007
First Posted Date November 16, 2007
Last Update Posted Date March 8, 2012
Study Start Date August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: November 15, 2007)
  • 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
Original Primary Outcome Measures Same as current
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 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
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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Extrahepatic Bile Duct Cancer
  • Pancreatic Cancer
Intervention
  • Genetic: proteomic profiling
  • Other: medical chart review
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
Estimated Enrollment
 (submitted: November 15, 2007)
502
Original Enrollment Same as current
Actual Study Completion Date April 2009
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00559598
Other Study ID Numbers 999904272
04-C-N272
CDR0000573190
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institutes of Health Clinical Center (CC)
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Lee E. Moore NCI - Occupational and Environmental Epidemiology Branch
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 2012