Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer
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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 |
- 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 |
| Study Completion Date: | April 2009 |
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 |
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 More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00559598 History of Changes |
| Obsolete Identifiers: | NCT00342979 |
| Other Study ID Numbers: | 999904272, 04-C-N272, CDR0000573190 |
| Study First Received: | November 15, 2007 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
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 May 16, 2013