Pancreas Registry and High Risk Registry

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT02775461
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2013
Status verified
Feb 2026
Primary completion
Jan 31, 2033
Completion
Jan 31, 2033

Study Design

Enrollment
1,368 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Personal or FHx of Pancreas Cancer or Pancreas Cysts
    Patients that have personal or family history of pancreatic cancer or pancreatic cysts.
  • Arm: Inflammatory Pancreatic Diseases
    Patients that have a personal or family history of pancreatic dysplasia or inflammatory pancreatic diseases.

Primary Outcome Measure

Number of individuals with pancreatic diseases [ Time Frame: 10 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Joyce Serebrenik
212-241-7269
Aimee Lucas, MD, MS (PRINCIPAL_INVESTIGATOR)
Mount Sinai WestNew YorkNew York10019
Joyce Serebrenik
(212) 241-7269
Aimee Lucas, MD, MS (PRINCIPAL_INVESTIGATOR)

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