Pancreatic Cancer Clinical Trial
— PCEDPOfficial title:
Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing
NCT number | NCT02206360 |
Other study ID # | WPH 1401 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | June 2024 |
Verified date | May 2024 |
Source | White Plains Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | June 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Any of the following: 1. Known carrier of either the BRCA2 or CDKN2A mutation; 2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer; 3. Individual with Peutz-Jeghers Syndrome; 4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject; 5. Both parents affected, any age: 6. Any first degree relative diagnosed with pancreatic cancer under age 50; 7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history Exclusion Criteria: 1. Any medical condition that contraindicates endoscopy or biopsy 2. Any medical condition that contraindicates MRI 3. Status post partial or complete resection of the pancreas 4. History of pancreatic cancer, either endocrine or exocrine 5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm). 6. diagnosis of dementia 7. Uncontrolled, current illness 8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl |
Country | Name | City | State |
---|---|---|---|
United States | White Plains Hospital | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
White Plains Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing. | Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy | 5 years | |
Secondary | Clinical outcomes which occur as a result of this Protocol | Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing. | 5 years | |
Secondary | Complications of any interventions as a result of this Protocol | Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death. | 5 years | |
Secondary | Non-Pancreatic cancers diagnosed while on this protocol | Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts. | 5 years |
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