Bladder Cancer Clinical Trial
Official title:
Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
NCT number | NCT02298998 |
Other study ID # | HSC20130177H |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | June 7, 2021 |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | June 7, 2021 |
Est. primary completion date | May 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study. | 2 years | ||
Primary | Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance. | 2 years | ||
Secondary | Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms. | 2 years | ||
Secondary | Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
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