Pancreas Registry and High Risk Registry
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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 |
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Recruitment Status :
Recruiting
First Posted : May 17, 2016
Last Update Posted : February 27, 2019
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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 |
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| 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 |
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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.
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Personal or FHx of Pancreas Cancer or Pancreas Cysts
Patients that have personal or family history of pancreatic cancer or pancreatic cysts.
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Inflammatory Pancreatic Diseases
Patients that have a personal or family history of pancreatic dysplasia or inflammatory pancreatic diseases.
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- 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
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 |
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
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
| Contact: Anne Aronson | 212-241-7269 | anne.aronson@mssm.edu | |
| Contact: Aimee Lucas, MD, MS | 212-241-0101 | aimee.lucas@mssm.edu |
| 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 | |
| Principal Investigator: | Aimee Lucas, MD, MS | Icahn School of Medicine at Mount Sinai |
Additional Information:
| 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 27, 2019 |
| Last Verified: | February 2019 |
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Family History of Pancreas Cancer Family History of Cancer Pancreas Cancer Chronic Pancreatitis Pancreatic Cyst BRCA1 |
BRCA2 Lynch Syndrome Peutz-Jeghers syndrome ATM mutation FAMMM Syndrome Pancreatitis |
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Pancreatic Neoplasms Pancreatic Cyst Pancreatitis Pancreatitis, Chronic Pancreatic Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms by Site |
Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Cysts Pancrelipase Pancreatin Gastrointestinal Agents |