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Identify individuals who are at moderate and high risk or predisposed to developing pancreatic cancer with a familial history in which data collected from this study will be used to identify clinical factors associated with early detection of pancreatic cancer.
Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. In 2015, there were 49,000 new diagnoses with 41,000 deaths . A recent analysis of the pedigrees in the National Familial Pancreatic Tumor Registry found that individuals with a family history of pancreatic cancer in first-degree relatives are at an increased risk of developing pancreatic cancer themselves. There are more than a dozen inherited germline mutations that increase the risk of pancreatic cancer in these family members. In an attempt to lower the number of individuals that develop advanced pancreatic cancer, an early-detection program is created to detect tumors at a stage early enough that treatment is likely to be successful. Numerous treatment options exist such as surveillance, radiation therapy, systemic therapy and surgery. Determining which treatment option will be implemented is based on the stage and grade of the tumor/cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hereditary high risk pancreatic cancer | Other | Data collection trial for hereditary high risk pancreatic cancer patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of imaging for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly. | Imaging includes CT/MRI abdomen with and without contrast using the pancreatic protocol, screening for solid pancreatic lesions, atypical cysts and IPMN, pancreatic duct dilatation, pancreas divisum. | Eight years |
| Evaluation of blood samples for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly. | Eight years | |
| Evaluation of endoscopic ultrasound for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly | Eight years |
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Inclusion Criteria:
Eligible subjects must be ≥ 18 years of age
Meet one of the following criteria:
All affected on the same side of the family (maternal/paternal) unless otherwise specified FDR = first degree relative (parent, sibling, child)
SDR = second degree relative (e.g., aunt, uncle, grandparent, half-sibling, niece and nephew)
TDR = third degree relative (e.g., cousin, half-aunt or half-uncle)
1 FDR with pancreatic cancer < age 55
-≥2 FDR, SDR or TDR with pancreatic cancer at any age
Genetic syndrome with pancreatic cancer
FDR or SDR with pancreatic cancer at any age and Ashkenazi ancestry
FDR or SDR with pancreatic cancer at any age and:
Family history of melanoma OR
Has previously had genetic testing and has been determined to have a pathogenic gene variant.
FDR with a pathogenic gene variant
Exclusion Criteria:
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2. Meet one of the following criteria:
All affected on the same side of the family (maternal/paternal) unless otherwise specified FDR = first degree relative (parent, sibling, child)
SDR = second degree relative (e.g., aunt, uncle, grandparent, half-sibling, niece and nephew)
TDR = third degree relative (e.g., cousin, half-aunt or half-uncle)
1 FDR with pancreatic cancer < age 55
-≥2 FDR, SDR or TDR with pancreatic cancer at any age
Genetic syndrome with pancreatic cancer
FDR or SDR with pancreatic cancer at any age and Ashkenazi ancestry
FDR or SDR with pancreatic cancer at any age and:
Family history of melanoma OR
Has previously had genetic testing and has been determined to have a pathogenic gene variant.
FDR with a pathogenic gene variant
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| Name | Affiliation | Role |
|---|---|---|
| Valentina Dalili-Shoaie, MD | Hoag Memorial Hospital Presbyterian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States |
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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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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |