Bladder CancerNCT02298998
Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
An observational study of Bladder Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on the American Urological Association (AUA) guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Intervention
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 7 Jun 2021
- How long will I take part?
- 2 Years
- 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 a history of low or low-intermediate risk non-muscle invasive bladder cancer. They are being followed with periodic examinations of their bladder as a means for cancer surveillance.
Who may be able to join
- Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer.
- Must have a negative cystoscopy following most recent biopsy.
- Must be able to give informed consent.
- Must be age 18 or older.
- Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines.
Who cannot join
- Have a history of invasive (>=T1) bladder cancer.
- Have a history of carcinoma-in-situ (CIS).
- Unable to give informed consent.
- < 18 or younger.
- Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements).
- Had a surveillance cystoscopy following most recent biopsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on the American Urological Association (AUA) guidelines.
Read the detailed description
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the EAU guidelines and the "control" refers to surveillance based on the AUA guidelines.
Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist's discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.
- Conditions
- Bladder Cancer
- Being tested
- Intervention, Control
- 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.
InterventionOther
Also called EAU surveillance
Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.
ControlOther
Also called AUA Surveillance
Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The intervention group refers to surveillance based on the EAU guidelines. Receives: Other: Intervention | |
| Control | The control group refers to surveillance based on the AUA guidelines. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
Measured: 2 years
Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.
Measured: 2 years
Secondary outcomes (2)
Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.
Measured: 2 years
Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMar 2013
- Primary completion28 May 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- 41 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298998
- Sponsor's protocol ID
- HSC20130177H
- Status last verified
- Jun 2021
- First submitted
- 14 Nov 2014
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung D, Kassouf W, Agnihotram R, Alday H, Tajzler C, Eskandari A, Breau R, Kulkarni G, Chung P, Fairey A, Lodde M, Hyndman E, Alimohamed N, Rendon R, Black P, Nayak JG. Outcomes Among Rural and Urban Patients With High-Risk Nonmuscle-Invasive Bladder Cancer: Results From the Canadian Bladder Cancer Information System. J Urol. 2026 Mar;215(3):286-293. doi: 10.1097/JU.0000000000004836. Epub 2025 Oct 30.
PubMed 41166647
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02298998
- Acronym / sponsor ID
- HSC20130177H
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 24 Nov 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.
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on the American Urological Association (AUA) guidelines.
Detailed description
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the EAU guidelines and the "control" refers to surveillance based on the AUA guidelines.
Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist's discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: InterventionThe intervention group refers to surveillance based on the EAU guidelines. |
| Control | – | Other: ControlThe control group refers to surveillance based on the AUA guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of low or low-intermediate risk non-muscle invasive bladder cancer. They are being followed with periodic examinations of their bladder as a means for cancer surveillance.
Key inclusion criteria (5 listed)
- Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer.
- Must have a negative cystoscopy following most recent biopsy.
- Must be able to give informed consent.
- Must be age 18 or older.
- Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines.
Key exclusion criteria (6 listed)
- Have a history of invasive (>=T1) bladder cancer.
- Have a history of carcinoma-in-situ (CIS).
- Unable to give informed consent.
- < 18 or younger.
- Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements).
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 |
|---|---|---|
| InterventionAlso: EAU surveillancePatients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance. | Other | Intervention |
| ControlAlso: AUA SurveillancePatients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years. | Other | Control |
Primary outcome
Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study.
Time frame: 2 years
Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance.
Time frame: 2 years
2 secondary outcomes
Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms.
Time frame: 2 years
Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches.
Time frame: 2 years
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 14 Jun 2021.
- Derived from this study: PubMed 41166647Chung D, Kassouf W, Agnihotram R, Alday H, Tajzler C, Eskandari A, Breau R, Kulkarni G, Chung P, Fairey A, Lodde M, Hyndman E, Alimohamed N, Rendon R, Black P, Nayak JG. Outcomes Among Rural and Urban Patients With High-Risk Nonmuscle-Invasive Bladder Cancer: Results From the Canadian Bladder Cancer Information System. J Urol. 2026 Mar;215(3):286-293. doi: 10.1097/JU.0000000000004836. Epub 2025 Oct 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 The University of Texas Health Science Center at San Antonio 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 5 inclusion and 6 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 14 Jun 2021. 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?
Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298998, which also lists 1 linked publication.
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 14 Jun 2021.