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

This study has been completed.
Sponsor:
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00615043
First received: February 1, 2008
Last updated: December 20, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention
Bladder Disease
 Procedure: Bladder biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tengion:

Primary Outcome Measures:
  • Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Tissue


Enrollment: 6
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TURBT group
Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens
 Procedure: Bladder biopsy
provision of bladder tissue via cystoscopic biopsy during planned TURBT

  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 TURBT

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615043

Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
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: NCT00615043     History of Changes
Other Study ID Numbers: TNG-CL007
Study First Received: February 1, 2008
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Tengion:
Transurethral resection of bladder tumor
TURBT

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urinary Bladder Diseases
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013