Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction (MBO—IR)
This study is currently recruiting participants.
Verified February 2010 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01073514
First received: February 21, 2010
Last updated: October 24, 2011
Last verified: February 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 21, 2010 | ||||||||
| Last Updated Date | October 24, 2011 | ||||||||
| Start Date ICMJE | December 2009 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01073514 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 | Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction | ||||||||
| Official Title ICMJE | Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction | ||||||||
| Brief Summary | To investigate bile culture and susceptibility test in patients with malignant biliary obstruction (MBO) or relation between bile, portal vein or vein culture and biliary infection. Also to get the information of bile metabonomics to find potential tumor marker .Culture of the organism is recognized as the "gold standard" for diagnosis of infection. Our research may be one of the first research on culture and susceptibility test in patients with MBO. The results of the trial research will be benefit to experiential therapy of MBO with biliary infection and diagnosis of MBO. |
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| Detailed Description | We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples. |
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| 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 | Retention: Samples With DNA Description: bile,blood and urine specimen |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Malignant obstructive jaundice (MBO) |
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| Condition ICMJE | Malignant Biliary Obstruction | ||||||||
| 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 | 300 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01073514 | ||||||||
| Other Study ID Numbers ICMJE | TMU-CIH-IR-001, ChiCTR-ONC-00000752 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Tianjin Medical University Cancer Institute and Hospital | ||||||||
| Study Sponsor ICMJE | Tianjin Medical University Cancer Institute and Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Tianjin Medical University Cancer Institute and Hospital | ||||||||
| Verification Date | February 2010 | ||||||||
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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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