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Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer (Sonoma)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00826982
First received: January 20, 2009
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2008
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic Cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care

Criteria

Inclusion Criteria:

  • Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases.
  • Patients who are scheduled for clinically indicated EUS

Exclusion Criteria:

  • Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease.
  • Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826982

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael Wallace, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00826982     History of Changes
Other Study ID Numbers: 07-006640, MCR SPORE (CA102701-05DJ), ACG (FNDT-1)
Study First Received: January 20, 2009
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013