Optical and Biochemical Biomarkers in Early Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.

Detailed Description
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Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum. From within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor. Once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning. This entire process from secretin injection to sample collection takes an average of 5 minutes. The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed. The top 10 candidate markers from discovery and validation on tissue (AUCs >0.95) and from pilot pancreatic-juice testing (AUCs >0.9) will be evaluated in this study. Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite treated using optimized methods. Then, an assay of aberrant methylation on target genes will be conducted using the QuARTS technique. Results will be normalized to either a human DNA marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic epithelium.

Official Title
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Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Synthetic Human Secretin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer. International normalized ratio (INR) less than 1.5 Platelet count >50,000 Exclusion Criteria: Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding Pregnant patients

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreas Cancer Subjects<br>Patients with pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure. | Drug: Synthetic Human Secretin<br>* Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.<br>* Other names: ChiRhoStim;|
| Control Subjects<br>Controls will receive Synthetic Human Secretin during an endoscopy procedure. Controls are at an elevated risk of pancreas cancer, including pancreatic cystic neoplasms. | Drug: Synthetic Human Secretin<br>* Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.<br>* Other names: ChiRhoStim;|
| Familial Pancreatic Cancer Subjects<br>Subjects who have a family history of pancreas cancer will receive Synthetic Human Secretin during an endoscopy procedure. | Drug: Synthetic Human Secretin<br>* Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.<br>* Other names: ChiRhoStim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylated DNA markers as measured by mean percentage of total human DNA per pancreatic juice volume | After pancreatic juice is collected, top 10 markers for pancreas cancer detection will be done from discovery and validation on tissue (AUC>.95) and from pilot pancreatic-juice testing (AUCs >0.9). | one year |