We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00559598
First Posted: November 16, 2007
Last Update Posted: March 8, 2012
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)
  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
  • 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559598


Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lee E. Moore NCI - Occupational and Environmental Epidemiology Branch
  More Information

ClinicalTrials.gov Identifier: NCT00559598     History of Changes
Obsolete Identifiers: NCT00342979
Other Study ID Numbers: 999904272
04-C-N272
CDR0000573190
First Submitted: November 15, 2007
First Posted: November 16, 2007
Last Update Posted: March 8, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type