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

Overview

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

Full Title of Study: “A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2008

Interventions

  • Procedure: Bladder biopsy
    • provision of bladder tissue via cystoscopic biopsy during planned TURBT

Arms, Groups and Cohorts

  • TURBT group
    • Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure
    • Time Frame: ongoing throughout study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tengion
  • Provider of Information About this Clinical Study
    • Sunita Sheth, MD Chief Medical Officer, Tengion, Inc
  • Overall Official(s)
    • Sunita Sheth, MD, Study Director, Tengion, Inc

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