Bladder CancerNCT02039310
Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
An observational study of Bladder Cancer, run by University of Michigan at 1 site in United States.
Trial summary
The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 31 Dec 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients meeting eligibility criteria will be recruited from genitourinary cancer clinics at the University of Michigan Comprehensive Cancer Center. Patients undergoing initial consultation, active treatment, or surveillance after endoscopic or intravesical therapy will be identified and screened. Interested patients will be counseled by Dr. Lee or her designee, who will review the rationale and benefits of the study, the potential risks and probability of their occurrence, and the procedures to minimize these risks. Patients who wish to enter the study will be asked to sign a consent form that meets the requirements of the University of Michigan IRB. A signed copy of the patient consent will be entered into the medical record.
Who may be able to join
- Histologic diagnosis of bladder carcinoma (any histology permitted)
- Planned treatment with radical cystectomy.
- Age 65 years or older at the time of radical cystectomy
- Able to give consent
- Neoadjuvant chemotherapy is permissible
- Prior malignancy is permissible, without evidence of disease for at least 2 years
- Concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible.
- Willingness to complete surgical follow-up at the University of Michigan for at least 6 months after radical cystectomy.
Who cannot join
- Evidence of metastatic bladder cancer
- Life expectancy less than one year
- Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed
Trial locations and contacts
1 site in 1 country.
About this study
The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.
- Conditions
- 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 |
|---|---|---|
| ≥ 65 years / opts for radical cystectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment Free Survival
Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startMar 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
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 MichiganThe 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Lee, University of Michigan
- Investigators
- Cheryl T Lee, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039310
- Sponsor's protocol ID
- HUM00057382
- Status last verified
- Jul 2017
- First submitted
- 15 Jan 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02039310
- Acronym / sponsor ID
- HUM00057382
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 17 Jan 2014 (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 proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ≥ 65 years / opts for radical cystectomy | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients meeting eligibility criteria will be recruited from genitourinary cancer clinics at the University of Michigan Comprehensive Cancer Center. Patients undergoing initial consultation, active treatment, or surveillance after endoscopic or intravesical therapy will be identified and screened. Interested patients will be counseled by Dr. Lee or her designee, who will review the rationale and benefits of the study, the potential risks and probability of their occurrence, and the procedures to minimize these risks. Patients who wish to enter the study will be asked to sign a consent form that meets the requirements of the University of Michigan IRB. A signed copy of the patient consent will be entered into the medical record.
Key inclusion criteria (8 listed)
- Histologic diagnosis of bladder carcinoma (any histology permitted)
- Planned treatment with radical cystectomy.
- Age 65 years or older at the time of radical cystectomy
- Able to give consent
- Neoadjuvant chemotherapy is permissible
Key exclusion criteria (3 listed)
- Evidence of metastatic bladder cancer
- Life expectancy less than one year
- Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed
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
Impairment Free Survival
Time frame: 6 months
Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.
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 27 Jul 2017.
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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.
Cheryl T Lee, MD principal investigator
University of Michigan
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 Michigan 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 8 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 27 Jul 2017. 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?
Impairment Free Survival (time frame: 6 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 27 Jul 2017.