Pancreatic Disease Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Jeanine Genkinger, Columbia University
ClinicalTrials.gov Identifier:
NCT01102556
First received: April 12, 2010
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition
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.

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1000
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)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas, or who have been identified to be at high-risk for developing pancreatic cancer.

Criteria

Inclusion Criteria:

  • Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas who are 18 years or older
  • Individuals identified to be high risk for developing pancreatic cancer who are 18 years or older based on the following criteria:
  • The modified clinical Bethesda criteria for HNPCC, which are as follows: individuals with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary, pancreatic, genitourinary, or gastric), including synchronous or metachronous lesions; individuals with colon cancer and a first degree relative with an HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age <45 years and the adenoma diagnosed at age <40 years); individuals with colon or endometrial cancer diagnosed at <50 years; individuals with right-sided colon cancer having an undifferentiated pattern (solid/cribiform) or signet cell histopathology diagnosed at <45 years; or individuals with adenomas diagnosed at <40 years.
  • Those with a personal or family history of other pancreatic cancer associated syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome, familial breast cancer syndrome associated with BRCA-2 or BRCA-1, hereditary pancreatitis, familial atypical multiple mole melanoma, and others.
  • Patients in a family with a genetically determined cancer predisposition syndrome.
  • Patients with a personal history of a gastrointestinal malignancy at age <45 years.
  • Individuals at high-risk based on personal or family history, but not related to a known pancreatic cancer syndrome include the following: those with a personal history of pancreatic cancer, or a pre-neoplastic pancreatic lesion; those with a family history of two or more individuals with cancer, at least one of which is reported to be a gastrointestinal malignancy; a history of early onset (<50 years) gastrointestinal cancer in the individual or a family member; a history of multiple primary cancers, at least one of which is a gastrointestinal primary, or a family member of an individual meeting this criterion.

Exclusion Criteria:

  • Inability to obtain informed consent for study enrollment.
  • Under the age of 18 years old.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102556

Contacts
Contact: Ashley Dikos 212-305-9812 ajd2147@columbia.edu
Contact: Vilma Rosario 212-305-6033 vr2222@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Ashley Dikos    212-305-9812    ajd2147@columbia.edu   
Contact: Vilma Rosario       vr2222@columbia.edu   
Principal Investigator: Jeanine Genkinger, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Jeanine Genkinger, PhD Columbia University
  More Information

No publications provided

Responsible Party: Jeanine Genkinger, Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01102556     History of Changes
Other Study ID Numbers: AAAA6154
Study First Received: April 12, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Pancreatic Cancer
Pre-Neoplastic Lesions
Pancreatic Cancer Surgery
High-Risk for Pancreatic Cancer
Tissue and Blood Bank for Pancreatic Cancer
Pancreatic Cancer Questionnaire

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014