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The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Ultrasound (EUS) Participants | High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Ultrasound (EUS) | Procedure | Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Abnormalities Detected by EUS | To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer. | Average of 5 years |
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Inclusion Criteria:
Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer
Peutz-Jeghers Syndrome (PJS) patients age>30
Hereditary pancreatitis patients
Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
Willingness to undergo radiographic evaluation if screening findings are abnormal
Exclusion Criteria:
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Individuals potentially at high-risk for developing pancreatic cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Aamir Dam, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States | ||
| Lehigh Valley Health Network |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
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|
|
| Allentown |
| Pennsylvania |
| 18105 |
| United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |