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

December 20, 2010 updated by: Tengion

A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients otherwise undergoing cystectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: tissue procurement
No intervention. Tissue procurement study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of bladder tissue from patients underogoing radical cystectomy
Time Frame: ongoing throughout study
ongoing throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tengion

Investigators

  • Study Director: Sunita Sheth, MD, Tengion, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 20, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TNG-CL005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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