Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt CC
| Tracking Information | |||||
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| First Received Date ICMJE | August 8, 2012 | ||||
| Last Updated Date | January 31, 2013 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | September 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of Abnormalities Detected by EUS [ Time Frame: Average of 5 years ] [ Designated as safety issue: No ] To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01662609 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt CC | ||||
| Official Title ICMJE | Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center | ||||
| Brief Summary | The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Individuals potentially at high-risk for developing pancreatic cancer. |
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| Condition ICMJE | Pancreatic Cancer | ||||
| Intervention ICMJE | Procedure: Endoscopic Ultrasound (EUS)
Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.
Other Name: ultrasound scope |
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| Study Group/Cohort (s) | Endoscopic Ultrasound (EUS) Participants
High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer.
Intervention: Procedure: Endoscopic Ultrasound (EUS) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | September 2017 | ||||
| Estimated Primary Completion Date | September 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01662609 | ||||
| Other Study ID Numbers ICMJE | MCC-14882 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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