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Trial record 2 of 10 for:    daniel lee | Recruiting, Not yet recruiting, Available Studies

Observation Versus Immediate Surgery of Low Risk Bladder Cancer

This study is currently recruiting participants.
Verified October 2017 by Daniel Lee, Vanderbilt University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02700724
First Posted: March 7, 2016
Last Update Posted: October 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Lee, Vanderbilt University Medical Center
  Purpose
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.

Condition Intervention
Bladder Cancer Other: Immediate Surgery Other: Observation Procedure: Surveillance Cystoscopy and Urinary Cytology

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Daniel Lee, Vanderbilt University Medical Center:

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

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

  • 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.


Estimated Enrollment: 100
Study Start Date: April 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Daniel Lee, MD daniel.lee.1@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States
Contact: D         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Daniel D. Lee, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Daniel Lee, Instructor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02700724     History of Changes
Other Study ID Numbers: 151898
First Submitted: December 7, 2015
First Posted: March 7, 2016
Last Update Posted: October 25, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases