ClinicalTrials.gov
ClinicalTrials.gov Menu

Pancreas Registry and High Risk Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02775461
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.


Condition or disease
Pancreas Cancer Pancreatitis Chronic Pancreatitis Pancreatic Cyst Family History of Pancreas Cancer Genetic Mutations

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Pancreas Disease and High Risk Registry
Study Start Date : March 2013
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2026


Group/Cohort
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 Measures :
  1. Number of individuals with pancreatic diseases [ Time Frame: 10 years ]
    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.


Biospecimen Retention:   Samples With DNA
Whole Blood samples for DNA, serum and plasma extraction.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • ≥ 2 close family members (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775461


Contacts
Contact: Anne Aronson 212-241-7269 anne.aronson@mssm.edu
Contact: Aimee Lucas, MD, MS 212-241-0101 aimee.lucas@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Anne Aronson    212-241-7269    anne.aronson@mssm.edu   
Principal Investigator: Aimee Lucas, MD, MS         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Aimee Lucas, MD, MS Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02775461     History of Changes
Other Study ID Numbers: GCO 13-0222
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by Icahn School of Medicine at Mount Sinai:
Chronic Pancreatitis
Pancreas Cancer
Pancreatic Cyst
BRCA1
BRCA2
Lynch Syndrome
Peutz-Jeghers syndrome
ATM mutation
FAMMM Syndrome
Pancreatitis
Family History of Pancreas Cancer
Family History of Cancer

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatitis
Pancreatic Neoplasms
Pancreatic Cyst
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Cysts
Pancrelipase
Pancreatin
Gastrointestinal Agents