Trials / Active Not Recruiting
Active Not RecruitingNCT02206360
Pancreatic Cancer Early Detection Program
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- White Plains Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Pancreatic Cancer
- Pancreas Cancer
- Pancreatic Adenocarcinoma
- Familial Pancreatic Cancer
- BRCA 1/2
- HNPCC
- Lynch Syndrome
- Hereditary Pancreatitis
- FAMMM
- Familial Atypical Multiple Mole Melanoma
- Peutz Jeghers Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Endoscopic Ultrasound | |
| PROCEDURE | Magnetic Resonance Imaging (MRI) |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2024-03-01
- Completion
- 2024-06-01
- First posted
- 2014-08-01
- Last updated
- 2024-05-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02206360. Inclusion in this directory is not an endorsement.