Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

NCT ID: NCT00559598

Last Updated: 2012-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 502 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2009-04-30

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.

Conditions

Extrahepatic Bile Duct Cancer; Pancreatic Cancer

Interventions

proteomic profiling

Intervention Type: GENETIC

medical chart review

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Lee E. Moore

Role: PRINCIPAL_INVESTIGATOR

NCI - Occupational and Environmental Epidemiology Branch

Other Identifiers

04-C-N272

Identifier Type: -

Identifier Source: secondary_id

CDR0000573190

Identifier Type: -

Identifier Source: secondary_id

999904272

Identifier Type: -

Identifier Source: org_study_id

NCT00342979

Identifier Type: -

Identifier Source: nct_alias