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

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ClinicalTrials.gov Identifier: NCT00577785
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : December 22, 2010
Sponsor:
Information provided by:
Tengion

Brief Summary:
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.

Condition or disease Intervention/treatment
Cystectomy Other: tissue procurement

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery
Study Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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.




Primary Outcome Measures :
  1. Evaluation of bladder tissue from patients underogoing radical cystectomy [ Time Frame: ongoing throughout study ]

Biospecimen Retention:   Samples Without DNA
Tissue


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients otherwise undergoing cystectomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577785


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Tengion
Investigators
Study Director: Sunita Sheth, MD Tengion, Inc

Responsible Party: Sunita Sheth, MD Chief Medical Officer, Tengion, Inc
ClinicalTrials.gov Identifier: NCT00577785     History of Changes
Other Study ID Numbers: TNG-CL005
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010

Keywords provided by Tengion:
cystectomy