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The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.
Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be covered by the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMILIAL PANCREATIC CANCER and/or GENE MUTATION | An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI/MRCP | Diagnostic Test | An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Stage Pancreatic Cancer or Precursor Lesions | Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population. | Through study completion, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serial Pancreatic MRI Screening | Utility of MRI as a screening tool for Pancreatic Cancer in the study population. | Through study completion, up to 3 years |
| Serum Bio-bank | Banking serum from participants to isolate circulating exosomes and circulating tumor DNA. |
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Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)
Registration-Exclusion Criteria:
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50-90 years of age. Strong family history of pancreatic cancer/ known genetic mutation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tammy Lo, APRN | Contact | Tammy.Lo@nuvancehealth.org | ||
| Pramila Krumholtz, RN | Contact | Pramila.Krumholtz@nuvancehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Richard Frank, MD | Nuvance Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvance Health | Recruiting | Norwalk | Connecticut | 06856 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35854467 | Derived | Kandiah J, Lo T, Jin D, Melchior L, Krebs TL, Anand N, Ingram S, Krumholtz P, Pandya D, Trinidad A, Dong XE, Seshadri R, Bauman J, Lee R, Frank RC. A Community-Based Pancreatic Cancer Screening Study in High-Risk Individuals: Preliminary Efficacy and Safety Results. Clin Transl Gastroenterol. 2022 Aug 1;13(8):e00516. doi: 10.14309/ctg.0000000000000516. Epub 2022 Jul 20. |
| Label | URL |
|---|---|
| An overview pancreatic cancer research at Nuvance Health | View source |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Data access requests will be reviewed on an individual basis post submission. Requestors may be required to sign a data access agreement.
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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Serum sample
| Through study completion, up to 3 years |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |