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Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure

NCT ID: NCT00615043

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-12-31

Brief Summary

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The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc.

Detailed Description

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Conditions

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Bladder Disease

Keywords

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Transurethral resection of bladder tumor TURBT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TURBT group

Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens

Bladder biopsy

Intervention Type PROCEDURE

provision of bladder tissue via cystoscopic biopsy during planned TURBT

Interventions

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Bladder biopsy

provision of bladder tissue via cystoscopic biopsy during planned TURBT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects 18-90 years and undergoing TURBT
* Willing and able to give signed informed consent

Exclusion Criteria

* Known active infection
* Known colonization with MRSA or VRE
* Receipt of blood or blood products for transfusion during the previous 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tengion

INDUSTRY

Sponsor Role lead

Responsible Party

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Tengion, Inc

Principal Investigators

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Sunita Sheth, MD

Role: STUDY_DIRECTOR

Tengion, Inc

Locations

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University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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TNG-CL007

Identifier Type: -

Identifier Source: org_study_id