Clinical trial NCT00559598: Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer
Official title: Use of Serum Proteome on the Early Diagnosis of Malignant Biliary-Pancreatic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extrahepatic Bile Duct Cancer
Pancreatic Cancer
Keywords: pancreatic cancer
extrahepatic bile duct cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-11-16
Enrollment: 502
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

Eligibility 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

Primary outcomes:
measure: Utility of the serum proteome pattern for early detection and diagnosis of pancreatic cancer and extrahepatic biliary tract cancer
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NCI - Occupational and Environmental Epidemiology Branch
name: Lee E. Moore
role: PRINCIPAL_INVESTIGATOR
References: