What will happen during the study?
Specimens for the IU Pancreatic Lesion Tissue/Fluid Bank and the Indiana Biobank will be derived from four sources:  1. Excess specimen not required for medical treatment or diagnosis which would normally be discarded; 2.Specimens that have served their purpose for medical treatment or diagnosis and are no longer needed; 3. Venipuncture of up to 36 cc of blood prior to each diagnostic or treatment procedure and up to two times after definitive treatment for their pancreatic lesion (may be drawn during their post-operative stay and at their first post-operative visit; every attempt will be made to time this blood draw with a blood draw required for routine care of patients); 4. Endoscopic Retrograde Cholangiopancreatography or surgery-guided pancreatic duct brushings or endoscopic ultrasound-guided fine needle aspirations (FNA) or core biopsy (CB) directed towards the translational component of pancreatic research trials.

Subjects undergoing an endoscopic ultrasound fine needle aspiration or core biopsy for a solid tissue mass may consent or withhold consent to 2-3 extra fine needle passes or an extra core biopsy for pancreatic research trials. Subjects undergoing ERCP or surgery (for solid tissue mass or cystic lesions) may also consent or withhold consent for pancreatic duct brushings (DB). There is minimal increase in risk (<1% FNA or DB; <5% CB) involved in having this extra tissue sampling as part of the routine practice in obtaining a tissue diagnosis.  These risks include pain, bleeding, infection, and pancreatitis.  

Such specimen types in addition to serum and/or plasma may include urine, pancreatic juice, bile, saliva, stool, pancreatic cyst fluid aspiration, fine needle, core or open biopsies of pancreas obtained through routine lab testing, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), percutaneous sampling or open biopsy in these patients with pancreatic lesions.  

All IU Pancreatic Lesion Tissue/Fluid Bank data will be entered into the IU Pancreatic Lesion Database (0209-67) by one of the patient’s physicians or the physician’s clinical staff to maintain confidentiality.  Data connected to the Indiana Biobank sample will be entered into the Indiana Biobank Database by Indiana Biobank staff.

Prospective collection of all specimens with the exception of blood and optional fine needle aspirations, core biopsies, or pancreatic duct brushings will have been collected solely for nonresearch purposes (such as medical treatment or diagnosis).  Patients who consent to venipuncture will undergo venipuncture of up to 36 cc of blood prior to each diagnostic or treatment procedure and up to two times after definitive treatment of their pancreatic lesion (may be drawn during their post-operative stay and at their first post-operative visit; every attempt will be made to time this blood draw with a blood draw required for routine care of patients).  Blood will be drawn by a phlebotomist or an experienced clinician to minimize discomfort. Every effort will be made to combine this venipuncture with other blood tests being performed for nonresearch purposes so patients will not need to undergo a separate procedure to obtain blood for this study.  The blood will be centrifuged, and the serum and/or plasma collected.  A pellet will also be obtained and shared with the Indiana Biobank. The serum and/or plasma specimens will be de-identified and labeled with a study number and stored at –20oC in the Cancer Research Institute, R3 C-541.    

The pellet sample collected following centrifugation will be placed into a tube which will be identified with the patient’s name, date of birth, gender and medical record number.  The pellet sample will be provided to the Indiana Biobank for DNA extraction. The Indiana Biobank case report form will be completed and sent along with the sample to the Indiana Biobank.  Information on this case report form will allow the Indiana Biobank to link the sample to the subject’s personal health information. The sample and personal health information will be used for future, unspecified research. It is impossible to know at this time all of the ways in which the specimen will be used in the future. Examples of studies that may be done include those that test why some people develop cancer or those that try to predict who will develop a particular disease. These studies may also try to find targets for future treatments.

IU Pancreatic Lesion Tissue/Fluid Bank patient specimens after de-identification will be analyzed by scientific co-investigators.  Novel biomarkers will be tested using the techniques of Western blot, Northern Blot, protein activity assays, proteomics and microarray.  Scientific data will be analyzed by the principal investigator with respect to the patient’s diagnoses.  This data will not be available to scientists during the testing for novel biomarkers to minimize any bias. The results will be entered into the de-identified database and numerically coded so analysis can be performed by biostatisticians/data managers and relevant conclusions made.  Indefinite accrual of patients for this study seems the most appropriate in order to establish a meaningful tissue/body fluid bank.  Candidate biomarkers are being discovered daily and will only be able to be analyzed if tissue/body fluid is available.  Many times tissue/body fluid may not be available because there is not enough sample or the specimen was not able to be processed quickly enough to avoid degradation (rendering it worthless for analysis).