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poor enrollment
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This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Surgery | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with disease progression (either stage or grade) | proportion of patients with disease progression (either stage or grade) | 12 months |
| Patient-reported Costs | out of pocket medical costs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel D. Lee, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000094463 | Transurethral Resection of Bladder |
| D019370 | Observation |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008722 | Methods |
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| Observation |
| Other |
|
|
| Surveillance Cystoscopy and Urinary Cytology | Procedure | Cytology and cystoscopy are done at the same time |
|
| 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. | At baseline and 3 months, 6 months, 9 months and 12 months. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008919 | Investigative Techniques |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |