NCT02775461 Pancreas Registry and High Risk Registry
| NCT ID | NCT02775461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Pancreas Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,368 participants |
| Start Date | 2013-03-01 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,368 participants in total. It began in 2013-03-01 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Aimee Lucas, MD, MS
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT02775461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02775461 currently recruiting?
Yes, NCT02775461 is actively recruiting participants. Contact the research team at joyce.serebrenik@mountsinai.org for enrollment information.
Where is the NCT02775461 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT02775461 clinical trial?
NCT02775461 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Aimee Lucas, MD, MS at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 1,368 participants.
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