CystectomyNCT00577785
Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery
An observational study of Cystectomy, run by Tengion at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cystectomy
- What is being tested?
- tissue procurement
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients otherwise undergoing cystectomy
Who may be able to join
- Subjects 18 to 90 years and undergoing a cystectomy surgery
- Willing and able to give signed informed consent
Who cannot join
- Known active infection
- Known colonization with MRSA or VRE
- Receipt of blood or blood products for transfusion during the previous 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery
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.
- Conditions
- Cystectomy
- Being tested
- tissue procurement
- Keywords
- cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue procurementOther
No intervention. Tissue procurement study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: tissue procurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bladder tissue from patients underogoing radical cystectomy
Measured: ongoing throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tengion
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sunita Sheth, MD, Study director, Tengion, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577785
- Sponsor's protocol ID
- TNG-CL005
- Status last verified
- Dec 2010
- First submitted
- 18 Dec 2007
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery
- ClinicalTrials.gov ID
- NCT00577785
- Acronym / sponsor ID
- TNG-CL005
- Conditions
- Cystectomy
- Keywords
- cystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- TengionIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystectomy group | – | Other: tissue procurementSubjects undergoing planned cystectomy who agree to provide bladder tissue from removed bladder post cystectomy and/or cystoscopic biopsy tissue prior to cystectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients otherwise undergoing cystectomy
Key inclusion criteria (2 listed)
- Subjects 18 to 90 years and undergoing a cystectomy surgery
- Willing and able to give signed informed consent
Key exclusion criteria (3 listed)
- Known active infection
- Known colonization with MRSA or VRE
- Receipt of blood or blood products for transfusion during the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue procurementNo intervention. Tissue procurement study. | Other | cystectomy group |
Primary outcome
Evaluation of bladder tissue from patients underogoing radical cystectomy
Time frame: ongoing throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita Sheth, MD study director
Tengion, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystectomy, run by Tengion at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of bladder tissue from patients underogoing radical cystectomy (time frame: ongoing throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2010; AzTrials last refreshed its copy on 4 Nov 2026.