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

This study has been completed.
Sponsor:
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00577785
First received: December 18, 2007
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

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 Intervention
Cystectomy
Other: tissue procurement

Study Type: Observational
Study Design: 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

Further study details as provided by Tengion:

Primary Outcome Measures:
  • Evaluation of bladder tissue from patients underogoing radical cystectomy [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Tissue


Enrollment: 52
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sunita Sheth, MD Chief Medical Officer, Tengion, Inc
ClinicalTrials.gov Identifier: NCT00577785     History of Changes
Other Study ID Numbers: TNG-CL005
Study First Received: December 18, 2007
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Tengion:
cystectomy

ClinicalTrials.gov processed this record on October 22, 2014