Pancreas Registry and High Risk Registry
Pancreas Disease and High Risk Registry
1 other identifier
observational
1,368
1 country
2
Brief Summary
The purpose of this study is to establish a registry of patients with pancreatic diseases. Patients included in the registry may include those with: pancreatic cancer, precancerous lesions of the pancreas, inflammatory lesions of the pancreas, cystic lesions of the pancreas, and patients at high-risk of pancreatic cancer such as those with a family history of pancreatic cancer or with a family history of a syndrome known to be associated with pancreatic cancer. Pancreatic cancer is the fourth leading cause of death from cancer in the United States. However, little is known about the development of pancreatic cancer and pancreatic diseases in individuals with the above conditions. Knowledge of how family history, environmental exposures, and inflammatory lesion of the pancreas contribute to the development of pancreatic cancer and pancreatic diseases is essential. You may qualify to take part in this research study because you have inflammation in the pancreas, a pancreatic cyst, pre-cancerous lesions of the pancreas, pancreatic cancer, a family history of pancreatic cancer, or a family history of a syndrome known to be associated with pancreatic cancer. We will also be collecting a blood sample from all participants for DNA isolation. Sometimes we are born with genes or DNA that give us an increased or decreased chance of developing an illness later in life. Genetic material will be isolated from your blood for further study. You may also choose to provide additional blood samples for serum and plasma extraction. Serum and plasma are components of the blood which can be used to measure indicators of disease in the blood, called biomarkers,for pancreatic diseases. Clinical data and biological specimens contained in this study may be used for a wide variety of future related studies to the cause, diagnosis, outcome and treatment of pancreatic cancer. Funds for conducting this research are provided by Mount Sinai.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2033
February 11, 2026
February 1, 2026
19.9 years
May 13, 2016
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of individuals with pancreatic diseases
Number of individuals and their family members who have pancreatic diseases and may be at increased risk of developing pancreatic cancer over normal population risk.
10 years
Study Arms (3)
Hereditary Pancreas Cancer Syndrome
Patients that have a diagnosis or any family history of a hereditary pancreas cancer syndrome, such as, but not limited to, Familial Pancreatic Cancer, hereditary pancreatitis, FAMMM syndrome, FAP and its variants, HNPCC (Lynch syndrome), Peutz-Jeghers syndrome, or BRCA1 and/or BRCA2 germline mutations.
Personal or FHx of Pancreas Cancer or Pancreas Cysts
Patients that have personal or family history of pancreatic cancer or pancreatic cysts.
Inflammatory Pancreatic Diseases
Patients that have a personal or family history of pancreatic dysplasia or inflammatory pancreatic diseases.
Eligibility Criteria
Participants with inflammation in the pancreas, a pancreatic cyst, pre-cancerous lesions of the pancreas, pancreatic cancer, a family history of pancreatic cancer, or a family history of a syndrome known to be associated with pancreatic cancer.
You may qualify if:
- At least 1 first degree relative affected with Pancreatic Cancer
- Any of (BRCA1, BRCA2, PALB2, ATM) mutations + 1 family member with Pancreatic Cancer
- mFAMMM (p16,CDKN2A mutations) + 1 family member with Pancreatic cancer
- Known mutation carrier for STK11 (Peutz Jeghers Syndrome)
- Lynch syndrome (HNPCC) + 1 family PDAC
- Known mutation carrier for Hereditary pancreatitis
- Individuals with a history of pancreatic cyst(s) (IPMN's) that measure ≥ 1 cm
You may not qualify if:
- Patients who do not speak English or Spanish
- Refusal by patient
- Individuals under the age of 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mount Sinai West
New York, New York, 10019, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Biospecimen
Whole Blood samples for DNA, serum and plasma extraction.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee Lucas, MD, MS
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Gastroenterology
Study Record Dates
First Submitted
May 13, 2016
First Posted
May 17, 2016
Study Start
March 1, 2013
Primary Completion (Estimated)
January 1, 2033
Study Completion (Estimated)
January 1, 2033
Last Updated
February 11, 2026
Record last verified: 2026-02