Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00559598

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:

MedlinePlus related topics: Cancer Pancreatic Cancer Pancreatic Diseases

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

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

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lee E. Moore

NCI - Occupational and Environmental Epidemiology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00559598 History of Changes
Obsolete Identifiers:	NCT00342979
Other Study ID Numbers:	CDR0000573190, NCI-04-C-N272
Study First Received:	November 15, 2007
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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 February 12, 2012