Bladder CancerNCT00829920
The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
An observational study of Bladder Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with muscle-invasive or metastatic bladder cancer with plans for cancer treatment.
Who may be able to join
- Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present.
- Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy.
- Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study.
- Subject must be 18 years of age or older
- Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study.
- Prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments.
- Predicted life expectancy of > 12 weeks.
Who cannot join
- Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80010
About this study
The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.
Read the detailed description
The measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer. The number of cells measured in these cancers has been shown to be prognostic. There is little information on the presence or importance of circulating tumor cells in bladder cancer. This trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer | Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of therapy
To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
Measured: baseline and then every 2 months
Secondary outcomes (3)
Presence of baseline CTC
Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease.
Measured: baseline and then every 2 months
Assessing insulin like growth factor
Determine the feasibility of assessing insulin like growth factor (IGF) I-R and c-Met by FISH in circulating tumor cells of patients with advanced bladder cancer.
Measured: baseline and then every 2 months
Correlation between CTC levels and clinical outcome
Evaluate for any potential correlation between CTC levels and clinical outcome
Measured: baseline and then every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas W. Flaig, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829920
- Sponsor's protocol ID
- 08-0018.cc
- Status last verified
- Jun 2013
- First submitted
- 25 Jan 2009
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
- ClinicalTrials.gov ID
- NCT00829920
- Acronym / sponsor ID
- 08-0018.cc
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Jan 2009 (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 investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.
Detailed description
The measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer. The number of cells measured in these cancers has been shown to be prognostic. There is little information on the presence or importance of circulating tumor cells in bladder cancer. This trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer | – | –Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with muscle-invasive or metastatic bladder cancer with plans for cancer treatment.
Key inclusion criteria (7 listed)
- Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present.
- Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy.
- Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study.
- Subject must be 18 years of age or older
- Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study.
Key exclusion criteria (1 listed)
- Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of therapy
Time frame: baseline and then every 2 months
To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
3 secondary outcomes
Presence of baseline CTC
Time frame: baseline and then every 2 months
Assessing insulin like growth factor
Time frame: baseline and then every 2 months
Correlation between CTC levels and clinical outcome
Time frame: baseline and then every 2 months
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 25 Jun 2013.
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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.
Thomas W. Flaig, MD principal investigator
University of Colorado, Denver
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 Bladder Cancer, run by University of Colorado, Denver 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 7 inclusion and 1 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 25 Jun 2013. 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?
Effect of therapy (time frame: baseline and then every 2 months). 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 25 Jun 2013.