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

Mayo Clinic

Status: Completed

Conditions: Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00826982

MCR SPORE (CA102701-05DJ)

07-006640

ACG (FNDT-1)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 1 patient group

Pancreatic Cancer