Recruiting

Pancreatic Diseases

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT02775461

Conditions

Pancreas Cancer

Pancreatitis

Chronic Pancreatitis

Pancreatic Cyst

Family History of Pancreas Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pancreas Cancer

Pancreatitis

Chronic Pancreatitis

Pancreatic Cyst

Family History of Pancreas Cancer

Study ID

NCT02775461

Start date

Mar 1, 2013

Status verified date

Feb, 2026

Completion date

Jan, 2033

Anticipated

Primary completion date

Jan, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who do not speak English or Spanish
  • Refusal by patient
  • Individuals under the age of 18 years

Study Design

Enrollment

1368 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Principal Investigator:

Aimee Lucas, MD, MS

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Aimee Lucas, MD, MS

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Pancreas Cancer
  • Chronic Pancreatitis
  • Pancreatic Cyst
  • BRCA1
  • BRCA2
  • Lynch Syndrome
  • Peutz-Jeghers syndrome
  • ATM mutation
  • FAMMM Syndrome
  • Pancreatitis
  • Family History of Pancreas Cancer
  • Family History of Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-11.