NCT00577785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 22, 2010

Status Verified

December 1, 2010

Enrollment Period

1.4 years

First QC Date

December 18, 2007

Last Update Submit

December 20, 2010

Conditions

Cystectomy

Keywords

cystectomy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of bladder tissue from patients underogoing radical cystectomy

    ongoing throughout study

Study Arms (1)

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

Interventions

tissue procurementOTHER

No intervention. Tissue procurement study.

cystectomy group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients otherwise undergoing cystectomy

You may qualify if:

  • Subjects 18 to 90 years and undergoing a cystectomy surgery
  • Willing and able to give signed informed consent

You may not qualify if:

  • Known active infection
  • Known colonization with MRSA or VRE
  • Receipt of blood or blood products for transfusion during the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue

MeSH Terms

Interventions

Tissue and Organ Procurement

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sunita Sheth, MD

    Tengion, Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 22, 2010

Record last verified: 2010-12

Locations

US(1)