Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00559598
First received: November 15, 2007
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Extrahepatic Bile Duct Cancer
Pancreatic Cancer
Genetic: proteomic profiling
Other: medical chart review

Study Type: Observational
Official Title: Use of Serum Proteome on the Early Diagnosis of Malignant Biliary-Pancreatic Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Utility of the serum proteome pattern for early detection and diagnosis of pancreatic cancer and extrahepatic biliary tract cancer [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 502
Study Start Date: August 2004
Study Completion Date: April 2009
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559598

Sponsors and Collaborators
Investigators
Principal Investigator: Lee E. Moore NCI - Occupational and Environmental Epidemiology Branch
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00559598     History of Changes
Obsolete Identifiers: NCT00342979
Other Study ID Numbers: 999904272, 04-C-N272, CDR0000573190
Study First Received: November 15, 2007
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
pancreatic cancer
extrahepatic bile duct cancer

Additional relevant MeSH terms:
Pancreatic Diseases
Pancreatic Neoplasms
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014