Pancreatic Disease Registry
The specific aims of this project are to create a registry, as well as a biospecimen bank for individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis, intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic intraepithelial neoplasia (PanIN) or have been determined to be at high-riskfor pancreatic cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples. Therefore, no hypothesis is to be tested. The personal data derived from the registry, correlated with biological information derived from the biospecimens will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection,and treatment of pancreatic cancer.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Year|
|Official Title:||PREDICT: Pancreatic Disease Cohort. A Registry and Biospecimen Bank To Better Understand Pancreatic Disease.|
- Creation of a registry and blood/tissue bank [ Time Frame: 1 year ] [ Designated as safety issue: No ]The primary aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer.
- Improvement in the diagnosis, prevention, detection, and treatment of pancreatic cancer. [ Time Frame: 10 years ] [ Designated as safety issue: No ]The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. The epidemiological data will be correlated with the biological information and will allow for future investigative studies of pancreatic cancer etiology and tumor biology. It is anticipated and hypothesized that the knowledge derived will lead to improvements in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
Biospecimen Retention: Samples With DNA
- Peripheral Blood Specimens: Three tubes of blood will be collected from each study participant. Two tubes will be EDTA-whole blood and one tube will be serum. Each tube will contain ~4-5 ml. The whole blood will be frozen and stored. A portion of the blood will be utilized to extract white blood cells that will be immortalized by EBV infection.
- Archived Fixed Tissue Samples: Tissue blocks from surgery performed at CUMC or elsewhere, will be requested after obtaining consent for study participation.
- Fresh Tissue Collection: At the time of surgery for any tumor resection, tumor tissue and adjacent normal tissue will be requested from the Pathology Department. At the time of endoscopy, aspirated fluid or biopsied tissue will be requested. No additional tissue will be resected beyond that required for surgical or endoscopic management. In no circumstance will tissue be obtained solely for the purpose of the study.
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Surgery Patients/High-risk Patients
Patients who have undergone surgery for pancreatic cancer or pre-neoplastic lesions of the pancreas will be accrued to the study. In addition, patients who are determined to be at high-risk for pancreatic cancer (with a significant family history) will also be recruited for study enrollment.
Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. According to the American Cancer Society facts and figures, approximately 43,920 people in the United Sates will be diagnosed with pancreatic cancer in 2012, and it is expected that 37,390 will die from the disease. The dismal prognosis of the disease is clearly depicted by the fact that its incidence approximates its mortality. Pancreatic cancer has a 95% case fatality rate.
The etiology of pancreatic cancer remains elusive and our knowledge of its precursors and natural history is preliminary and incomplete. The uniform fatality of the disease merits priority attention in the search for its cause.
Due to the rapid progression of the disease, early detection and prevention provides the best hope for reducing morbidity and mortality. However, the few screening tests available for early detection and/or prevention of neoplastic lesions are poorly studied and prohibitively impractical in the general population. Further, few pancreatic cancer risk factors are well established or widely accepted. Advanced age, family history, cigarette smoking, diabetes, and some dietary risk factors are established or suspected risk factors.
Due to the high volume of individuals seen at the pancreas center, we plan on enrolling 500+ individuals per year who have either been diagnosed with pancreatic disease or are at high risk for developing pancreatic cancer. All participants enrolled during a clinic/non clinic visit at CUMC will undergo a baseline visit and up to 3 subsequent visits. Additionally, based on the different conditions of pancreatic disease that we are enrolling, not all subjects will participate in all aspects of the program. For example, only individuals with cancer or pre-neoplastic lesions will have tissue collected and banked.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102556
|Contact: Ashley Dikosfirstname.lastname@example.org|
|Contact: Vilma Rosarioemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Ashley Dikos 212-305-9812 firstname.lastname@example.org|
|Contact: Vilma Rosario email@example.com|
|Principal Investigator: Jeanine Genkinger, PhD|
|Principal Investigator:||Jeanine Genkinger, PhD||Columbia University|