The Role of MicroRNA in the Diagnosis, Prognosis and Response to Treatment in Pancreatic Cancer

Specific aims of the study include:

• To obtain serum samples from patients with newly diagnosed pancreatic cancer at baseline before treatment and monthly throughout treatment.
• To analyze the miRNA profiles present at each time point.
• To determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
• To determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.

Inclusion criteria

• Have biopsy proven adenocarcinoma of the pancreas
• Have initially inoperable disease, classified as either locally advanced or metastatic disease

• Recurrent disease after a Whipple procedure is allowed
• Patients who are able to undergo resection after neoadjuvant therapy will continue to be followed after resection
• Have radiographically measurable disease
• Have an ECOG performance status of 2 or less
• Be willing to contribute the required information and specimens
• Provide written signed consent to participate

Exclusion criteria

• Having received prior anti-cancer treatments for metastatic pancreatic cancer
• Concurrently receiving systemic therapy for another cancer except androgen deprivation therapy for stable/controlled prostate cancer
• Presence of other active cancer except for: adequately treated local basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of trial. Other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for > 5 years is allowable