Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— Sonoma  

Official title:

Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826982
• Other study ID #: 07-006640
• Secondary ID: MCR SPORE (CA102
• Status: Completed
• Start date: January 2008

Study information

• Verified date: April 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		End of study
Secondary	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		End of study