Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Pancreatic Cancer

• Registration Number: NCT00559598
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Completion: 2009-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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