Bladder CancerNCT02700724
Observation Versus Immediate Surgery of Low Risk Bladder Cancer
A study testing Immediate Surgery, Observation and Surveillance Cystoscopy and Urinary Cytology in people with Bladder Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Immediate Surgery, Observation and Surveillance Cystoscopy and Urinary Cytology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 19 Jul 2018
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:
- total tumor burden ≤3cm in size (multiple lesions permitted)
- low grade appearance (grade 1 or grade 2)
- noninvasive appearance (Ta)
- no history of carcinoma in situ (CIS) or lesions concerning for CIS
- negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)
Who cannot join
- High grade and/or invasive and/or carcinoma in situ disease
- Concomitant upper tract urothelial carcinoma
- Any patient who is pregnant or who may have plans to become pregnant.
- Positive cytology
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee
About this study
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- Immediate Surgery, Observation, Surveillance Cystoscopy and Urinary Cytology
- 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.
Immediate SurgeryOther
Also called Transurethral Resection of Bladder Tumor
ObservationOther
Also called Active Surveillance
Surveillance Cystoscopy and Urinary CytologyProcedure or surgery
Cytology and cystoscopy are done at the same time
| Study group | Role | What they receive |
|---|---|---|
| Observation | Other | Patients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire. Receives: Other: Observation; Procedure: Surveillance Cystoscopy and Urinary Cytology |
| Immediate Surgery | Other | Patients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences. Receives: Other: Immediate Surgery; Procedure: Surveillance Cystoscopy and Urinary Cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
An event is a complication of any kind, including bleeding requiring blood transfusion, bladder perforation, urinary tract infection, readmission to the hospital, and progression of disease.
Measured: 12 months
Secondary outcomes (3)
Proportion of patients with disease progression (either stage or grade)
proportion of patients with disease progression (either stage or grade)
Measured: 12 months
Patient-reported Costs
out of pocket medical costs
Measured: At baseline and 3 months, 6 months, 9 months and 12 months.
Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
Measured using the EORTC QLQ-NMIBC24, which is a 24-item questionnaire for patients with superficial bladder cancer. This will be assessed at baseline and every 3 months during the study.
Measured: At baseline and 3 months, 6 months, 9 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
Why it stopped: poor enrollment
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 Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lee, Vanderbilt University Medical Center
- Investigators
- Daniel D. Lee, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700724
- Sponsor's protocol ID
- 151898
- Status last verified
- Aug 2018
- First submitted
- 7 Dec 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Versus Immediate Surgery of Low Risk Bladder Cancer
- ClinicalTrials.gov ID
- NCT02700724
- Acronym / sponsor ID
- 151898
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 7 Mar 2016 (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.
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | Other | Other: Observation, Procedure: Surveillance Cystoscopy and Urinary CytologyPatients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire. |
| Immediate Surgery | Other | Other: Immediate Surgery, Procedure: Surveillance Cystoscopy and Urinary CytologyPatients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:
- total tumor burden ≤3cm in size (multiple lesions permitted)
- low grade appearance (grade 1 or grade 2)
- noninvasive appearance (Ta)
- no history of carcinoma in situ (CIS) or lesions concerning for CIS
Key exclusion criteria (4 listed)
- High grade and/or invasive and/or carcinoma in situ disease
- Concomitant upper tract urothelial carcinoma
- Any patient who is pregnant or who may have plans to become pregnant.
- Positive cytology
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 |
|---|---|---|
| Immediate SurgeryAlso: Transurethral Resection of Bladder Tumor | Other | Immediate Surgery |
| ObservationAlso: Active Surveillance | Other | Observation |
| Surveillance Cystoscopy and Urinary CytologyCytology and cystoscopy are done at the same time | Procedure or surgery | Immediate Surgery, Observation |
Primary outcome
Event-Free Survival
Time frame: 12 months
An event is a complication of any kind, including bleeding requiring blood transfusion, bladder perforation, urinary tract infection, readmission to the hospital, and progression of disease.
3 secondary outcomes
Proportion of patients with disease progression (either stage or grade)
Time frame: 12 months
Patient-reported Costs
Time frame: At baseline and 3 months, 6 months, 9 months and 12 months.
Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
Time frame: At baseline and 3 months, 6 months, 9 months and 12 months.
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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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.
Daniel D. Lee, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Surgery, Observation and Surveillance Cystoscopy and Urinary Cytology in people with Bladder Cancer, run by Vanderbilt University Medical Center 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Aug 2018. 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 was stopped early (reason given: poor enrollment). Results are not available in the source record.
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?
Event-Free Survival (time frame: 12 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 13 Aug 2018.