About this trial
Aberrant miRNA production has been linked to a wide range of human cancers and shown to play important roles in their genesis and growth. These miRNA can be detected in the blood and tumors of patients with cancer. The investigators hypothesize that the detection of certain miRNAs present in the blood/serum of patients with pancreatic cancer may be important to the early diagnosis of the disease. Furthermore, the investigators hypothesize that miRNA detection in PC patients will yield prognostic information and help predict the response to treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Individuals with new diagnoses of unresectable pancreatic cancer, or recurrent pancreatic cancer following a Whipple procedure
Trial design
Ecologic or community
Prospective
Treatments tested in this trial
Blood draw
Procedure/SurgeryIndividuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
Treatment groups
Trial outcomes
Primary outcomes
Analysis of miRNA profile
Analyze the miRNA profiles present at each time point.
Secondary outcomes
PCR miRNA validation
Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test.
miRNA PCR expression
Determine miRNAs whose levels correlate with treatment response, both in patients with and without elevations in the serum tumor marker CA 19-9.
Sponsors and contacts
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