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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 21, 2006 | ||||||||
| Last Updated Date | August 6, 2009 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00414843 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Storage of Bile From Routine Procedures to Study Risk Factors | ||||||||
| Official Title ICMJE | A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk | ||||||||
| Brief Summary | The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk. |
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| Detailed Description | The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Other, Other | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | December 2020 | ||||||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00414843 | ||||||||
| Responsible Party | Mary Maluccio, Principal Investigator, Indiana University | ||||||||
| Study ID Numbers ICMJE | 0611-55, IUCRO-0176 | ||||||||
| Study Sponsor ICMJE | Indiana University School of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||||||
| Verification Date | August 2009 | ||||||||
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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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