Changes in Biomarkers From Blood Over Time in Patients With Pancreatic Adenocarcinoma

This is a single-institutional, prospective study at the Johns Hopkins Hospital which will be conducted from January 1, 2015 to December 31, 2018. All patients who present to the Johns Hopkins Hospital with a pancreatic adenocarcinoma (PDAC) for evaluation of treatment by chemotherapy, radiation therapy, and/or surgery will be approached to participate in this study, but only those who consent to the study will be included. All patients who consent to participate in this trial will have blood drawn (approximately 50 ml or 3-4 tablespoons) at the time of diagnosis but before any treatment had been administered. Further blood will be drawn after any treatment. For example, those patients that undergo surgical resection will also have blood drawn after resection prior to discharge. Those patients that undergo treatment with chemotherapy, radiation therapy, and or biologic/vaccine therapy will have blood drawn once after this treatment is completed. If a patient undergoes chemotherapy and then surgical resection, he or she will have blood drawn after chemotherapy but before surgical resection, and then again after surgical resection, all in addition to the pre-treatment blood sample (see schema included in IRB). For the first 2 years following surgery samples will be collected every 3-4 months. Beyond that the investigators will collect samples every 6 months for the next two years. For all patients found to be alive and disease free beyond 4 years after surgery samples will be collected once every year. This blood will be stored in the investigators' research facility and as such will be labeled with a de-identified code. If a patient refuses further blood draws at any time during the study or is loss to follow-up, the samples that have been collected will still be utilized.

The blood will be processed on the day of collection, within 6 hours of being drawn. Twenty (20) ml of blood, collected in two purple topped tubes, will be used for isolation of circulating tumor cells (CTCs) through the Isolation by Size of Epithelial Tumor Cells assay (ISET), which separates tumor cells by size onto a membrane which can be used for further experiments. These 20 ml of blood will be mixed with ISET buffer per standard protocol and filtered through the ISET machine onto membranes. These membranes will be stored at -20 degrees C under a de-identified number, and remain at these conditions for several years with full preservation of the cells. Further experiments will be done on these membranes, which include immunofluorescent staining, laser capture microscopy, and genetic analysis. The remaining 30 ml of blood, collected in red and purple topped tubes, will be processed by a standard protocol within 6 hours of collection. Blood will be double spun to remove white blood cells, and plasma and will be frozen. Driver gene mutations characterized in the resected tumors will be monitored by digital droplet Polymerase Chain Reaction (ddPCR), including the Kirsten rat sarcoma viral oncogene homolog (k-ras), p53, p16/cdkn2a and the Deleted in Pancreatic Cancer-4 gene (DPC4/SMAD4) to identify the presence of ctDNA and whether levels are rising.

Data will be collected, de-identified and analyzed as a single dataset at the Johns Hopkins Hospital. Data will be obtained from patient electronic and paper clinical charts from the John Hopkins Hospital starting on 1/1/2015, with only data in existence as of 1/1/2015 collected. More specifically, radiology, chemotherapy, operative and pathology reports, discharge summaries, and clinic notes will be reviewed and data from these sources collected. For patients lost to follow-up, the Social Security Death Index (but will not need to collect social security numbers) will be searched for evidence of death. Collected patient data will be entered into a dedicated database. Data will only be collected in order to correlate outcomes and tumor characteristics with the biomarkers identified during this study. Following data accrual and prior to analysis, all personal identifiers will be deleted and no identifiable information will be present at the time of statistical analysis. The subject data generated will not appear in the subject's medical record and will be used for research purposes only. The data will be recorded in a password-protected, secure database within the Principal Investigator's office and will be accessible only by the key personnel. After all data for a particular subject is collected, the subject's identity will be deleted to assure confidentiality.

The data that are collected in this study will not be used for the clinical management of any patient on study.

Inclusion/Exclusion Criteria