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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV, Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: Blood draw


Participation Criteria
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Eligibility Criteria
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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 Be willing to contribute the required information and specimens Provide written signed consent to participate Be eligible to receive multi-agent chemotherapy for the first line treatment of pancreatic cancer Have a predicted life expectancy of at least 3 months 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New Unresectable Pancreatic Cancer<br>Individuals with biopsy-proven adenocarcinoma of the pancreas, classified as locally advanced or metastatic disease | Procedure: Blood draw<br>* Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw<br>|
| Control<br>Healthy individuals without cancer diagnoses to provide reference microRNA | Procedure: Blood draw<br>* Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of miRNA profile | Analyze the miRNA profiles present at each time point. | Through study completion, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR miRNA validation | Determine miRNAs that may distinguish pancreatic patients from unaffected individuals. This could be developed into a diagnostic test. | Through study completion, up to 5 years | 
| 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. | Through study completion, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Pancreas, Biomarker