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Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery

NCT ID: NCT00577785

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

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

Brief Summary

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The objective of this study is to obtain bladder tissue specimens from patients otherwise undergoing cystectomy for use in research and training of personnel at Tengion, Inc.

Detailed Description

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Conditions

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Cystectomy

Keywords

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cystectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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cystectomy group

Subjects undergoing planned cystectomy who agree to provide bladder tissue from removed bladder post cystectomy and/or cystoscopic biopsy tissue prior to cystectomy

tissue procurement

Intervention Type OTHER

No intervention. Tissue procurement study.

Interventions

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tissue procurement

No intervention. Tissue procurement study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 to 90 years and undergoing a cystectomy surgery
* 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 Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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TNG-CL005

Identifier Type: -

Identifier Source: org_study_id