Clinical Trial: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Brief Summary: The major goal of this project is to reduce unnecessary pancreatic resections, namely resection in those patients with non-regional lymph node metastatses that cannot be cured with surgical resection. By combined minimally invasive methods for non-surgical biopsy and highly sensitive molecular assays for cancer cells, we believe we can increase the ability to detect distant lymph node metastases prior to surgical resection, and direct those patients for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR) of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: To determine the if molecular biomarkers increase the sensitivity by at least 5% for detection of malignant lymph nodes in patients with pancreatic ductal adenocarcinoma as compared to EUS-FNA cytology of lymph nodes alone. [ Time Frame: End of study ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine the degree of RNA overexpression of pancreas cancer specific biomarkers in the pre-operative fine needle aspirate of lymph nodes and tumors of patients with pancreatic cancer using a set of pancreas cancer specific biomarkers [ Time Frame: End of study ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: January 20, 2009
Date Started: January 2008
Date Completion:
Last Updated: May 15, 2012
Last Verified: May 2012