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Clinical Trial Details — Status: Active, not recruiting

Administrative data

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

Study information

Verified date May 2024
Source White Plains Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

Interested individuals can be referred by physicians, or by family or friends. Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk. Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program. We have a weekly review of all calls made and of all enrollments. We have a monthly meeting to review all proceeding regarding the study. Our IRB routinely reviews the proceedings of the study Our institution has a monthly Clinical research Committee meeting.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Endoscopic Ultrasound

Magnetic Resonance Imaging (MRI)


Locations

Country Name City State
United States White Plains Hospital White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
White Plains Hospital

Country where clinical trial is conducted

United States, 

Outcome

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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