Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure
This study has been completed.
Sponsor:
Tengion
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00615043
First received: February 1, 2008
Last updated: December 20, 2010
Last verified: December 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 1, 2008 | ||||
| Last Updated Date | December 20, 2010 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00615043 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 | Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure | ||||
| Official Title ICMJE | A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures | ||||
| Brief Summary | The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc. |
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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 | Retention: Samples Without DNA Description: Tissue |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients otherwise undergoing TURBT |
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| Condition ICMJE | Bladder Disease | ||||
| Intervention ICMJE | Procedure: Bladder biopsy
provision of bladder tissue via cystoscopic biopsy during planned TURBT |
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| Study Group/Cohort (s) | TURBT group
Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens
Intervention: Procedure: Bladder biopsy |
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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 | Completed | ||||
| Enrollment ICMJE | 6 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | September 2008 (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 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00615043 | ||||
| Other Study ID Numbers ICMJE | TNG-CL007 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sunita Sheth, MD Chief Medical Officer, Tengion, Inc | ||||
| Study Sponsor ICMJE | Tengion | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tengion | ||||
| Verification Date | December 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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