A Study Comparing the Outcomes of Observation versus Immediate Surgery for Low Risk Bladder Cancer
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-001592
NCT ID: NCT02700724
Sponsor Protocol Number: 011222
About this study
This trial is a randomized study comparing effectiveness, morbidity, and cost of observation versus immediate surgery for low grade, noninvasive bladder cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 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)
Exclusion Criteria
- High grade and/or invasive and/or carcinoma in situ disease
- Concomitant upper tract urothelial carcinoma
- Is pregnant or may have plans to become pregnant
- Positive cytology
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Stephen Boorjian, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available