The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observation Versus Immediate Surgery of Low Risk Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700724
Recruitment Status : Terminated (poor enrollment)
First Posted : March 7, 2016
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Lee, Vanderbilt University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Other: Immediate Surgery Other: Observation Procedure: Surveillance Cystoscopy and Urinary Cytology Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observation Versus Immediate Surgery of Low Risk Bladder Cancer
Study Start Date : April 2016
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Observation
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.
 Other: Observation
Other Name: Active Surveillance

Procedure: Surveillance Cystoscopy and Urinary Cytology
Cytology and cystoscopy are done at the same time
Immediate Surgery
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.
 Other: Immediate Surgery
Other Name: Transurethral Resection of Bladder Tumor

Procedure: Surveillance Cystoscopy and Urinary Cytology
Cytology and cystoscopy are done at the same time


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion of patients with disease progression (either stage or grade) [ Time Frame: 12 months ]
    proportion of patients with disease progression (either stage or grade)

  2. Patient-reported Costs [ Time Frame: At baseline and 3 months, 6 months, 9 months and 12 months. ]
    out of pocket medical costs

  3. Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24 [ Time Frame: At baseline and 3 months, 6 months, 9 months and 12 months. ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Any patient who is pregnant or who may have plans to become pregnant.
  • Positive cytology
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700724


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Daniel D. Lee, MD Vanderbilt University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Daniel Lee, Instructor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02700724    
Other Study ID Numbers: 151898
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases