Clinical trialObservationalCompleted
Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer
Use of Serum Proteome on the Early Diagnosis of Malignant Biliary-Pancreatic Disease
- Outcome
- Finished, no results posted
- Phase
- Observational
- Status
- Completed
- Study type
- Observational
- Start
- August 2004
- Ended
- April 2009
- Enrollment
- 502 participants
- Sites
- 0
- Primary outcomes
- 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
- Sponsor type
- NIH
- Results posted
- No
- Last update
- 8 March 2012
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Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Genetic: proteomic profiling.
Intervention public domain (ClinicalTrials.gov)
Other: medical chart review.
Primary outcome public domain (ClinicalTrials.gov)
Utility of the serum proteome pattern for early detection and diagnosis of pancreatic cancer and extrahepatic biliary tract cancer. Time frame: .
Primary outcome public domain (ClinicalTrials.gov)
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. Time frame: .
Primary outcome public domain (ClinicalTrials.gov)
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. Time frame: .
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 502 participants (estimated).