Pancreatic and Gastrointestinal Tumor Registry and Tissue Collection (SPORE)
This study is currently recruiting participants.
Verified March 2013 by University of Alabama at Birmingham
Sponsor:
Charles Mel Wilcox, MD
Collaborator:
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584363
First received: December 24, 2007
Last updated: March 13, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 24, 2007 | ||||||||
| Last Updated Date | March 13, 2013 | ||||||||
| Start Date ICMJE | June 2004 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To diagnose Pancreatic Cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00584363 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Preventing patient form being misdiagnosed [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pancreatic and Gastrointestinal Tumor Registry and Tissue Collection | ||||||||
| Official Title ICMJE | Pancreatic and Gastrointestinal Tumor Registry and Tissue Collection (UAB/UMN SPORE in Pancreatic Cancer) | ||||||||
| Brief Summary | The purpose of the study is to collect pancreatic tissue, blood and urine from adults to study pancreatic abnormalities. |
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| Detailed Description | The aim of the study is to standardize, collect and share pancreatic cancer related information, to be used for research purposes only by researchers from different participating institutions/centers. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Specimens are frozen and stored |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Adults 19 years of age or older, pancreatic cancer patients at the University of Alabam at Birmingham. |
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| Condition ICMJE | Pancreatic Cancer | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| 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 | 600 | ||||||||
| Estimated Completion Date | June 2015 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 19 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00584363 | ||||||||
| Other Study ID Numbers ICMJE | F040514008, #000185970, 2P50CA101955 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Charles Mel Wilcox, MD, University of Alabama at Birmingham | ||||||||
| Study Sponsor ICMJE | Charles Mel Wilcox, MD | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||||||
| Verification Date | March 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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