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Improving Sensitivity of Urine Cytology for Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bladder Cancer focused on measuring Cytology, Whole body massage vibration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Only adult male subjects who will not have surgery within a period of 2 weeks.
  • Over the age of 18
  • Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days

Exclusion Criteria:

  • Cognitive impairment resulting in the inability to give informed consent
  • Lack of spoken and written English resulting in the inability to give informed consent
  • Presence of infectious disease
  • Insulin dependent diabetes mellitus
  • Endogenous osteosynthetical material implants
  • Knee or hip prosthesis
  • Pacemaker
  • Epilepsy
  • Musculo-skeletal disorders
  • Weight in excess of 250 pounds
  • Poor circulation

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibration

Arm Description

Whole body vibration applied to a group of 20 bladder cancer patients.

Outcomes

Primary Outcome Measures

Number of Cancer Cells
Number of Cancer Cells in a 50 ml Urine

Secondary Outcome Measures

Full Information

First Posted
April 1, 2013
Last Updated
January 30, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01826097
Brief Title
Improving Sensitivity of Urine Cytology for Bladder Cancer
Official Title
Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Study Start Date
January 2013 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Can a commercially available vibrating chair increase the number of urothelial cells in a urine sample of healthy participants non-invasively? The investigators plan is participants will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour. Then, urine samples will be collected and examined for urothelial cell concentration for both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Cytology, Whole body massage vibration

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibration
Arm Type
Experimental
Arm Description
Whole body vibration applied to a group of 20 bladder cancer patients.
Intervention Type
Device
Intervention Name(s)
La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration
Primary Outcome Measure Information:
Title
Number of Cancer Cells
Description
Number of Cancer Cells in a 50 ml Urine
Time Frame
up to 24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only adult male subjects who will not have surgery within a period of 2 weeks. Over the age of 18 Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days Exclusion Criteria: Cognitive impairment resulting in the inability to give informed consent Lack of spoken and written English resulting in the inability to give informed consent Presence of infectious disease Insulin dependent diabetes mellitus Endogenous osteosynthetical material implants Knee or hip prosthesis Pacemaker Epilepsy Musculo-skeletal disorders Weight in excess of 250 pounds Poor circulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trinity Bivalacqua, MD/PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John J Kim, BS
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Improving Sensitivity of Urine Cytology for Bladder Cancer

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