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Bladder Cancer Screening Trial

Primary Purpose

Bladder Cancer, Urothelial Carcinoma, Hematuria

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urinalysis
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bladder Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 50 Smoking: ≥15 pack-year smoking history Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners Exclusion Criteria: Prior history of bladder, kidney, or prostate cancer Prior evaluation of micro or gross hematuria within the last 2 years Do not provide informed consent

Sites / Locations

  • University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BCa Early Screening Group

Historical Control Group

Arm Description

All participants undergo Urinalysis testing every 6 months for 2 years. Based on the RBC count, each participant will go through each of the screening procedures : [cystoscopy + Upper tract imaging] or [urine marker cancer testing with Cxbladder triage + Upper tract imaging] or [Repeat urinalysis] Patients with suspicious findings on cystoscopy or imaging will get treatment as per standard of care. Their outcomes will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).

This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).

Outcomes

Primary Outcome Measures

Incidence of Bladder cancer (BCa)
Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.

Secondary Outcome Measures

Smoking cessation
Smoking cessation is measured by number of participants who were referred to smoking cessation treatment
Screening interval
Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant
Screening interval
Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant
Number of participants with positive/ negative markers and findings on cystoscopy
Performance of urinalysis and molecular markers is assessed by the count of participants with positive/ negative markers and findings on cystoscopy

Full Information

First Posted
December 1, 2022
Last Updated
July 17, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05646485
Brief Title
Bladder Cancer Screening Trial
Official Title
Optimal Screening Strategy for Bladder Cancer in at Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is currently no accepted screening strategy for patients at high risk of developing bladder cancer. This study will ask patients to complete a urine test every 6 months for 2 years to help assess if routine screening helps finding bladder cancer at an earlier stage.
Detailed Description
Bladder cancer is the 4th most common cancer in men and 6th most common cancer overall with over 80,000 new cases in the US per year. The most common causes of bladder cancer are smoking and it is usually found in patients over the age of 50. By the time it is diagnosed, the disease is often advanced since there are few warning signs other than seeing blood in the urine. Screening is currently accepted practice for colon, cervical, and breast cancer. However, there is not an accepted screening methodology for bladder cancer. Bladder cancer is currently detected in 2-5% of patients who have microhematuria on routine urinalysis, a cheap, non-invasive test obtained by many primary care physicians. Bladder cancer diagnosed by microscopic blood on urinalysis is often lower stage than patients diagnosed with visible blood. Urine testing, therefore, offers a simple screening mechanism that can be tailored to patients at higher risk for bladder cancer based on age, tobacco exposure and other risk factors. In conjunction with routine traditional urinalysis testing, there are advances in urine molecular markers which utilize protein and genetic alterations resulting in a higher sensitivity and specificity for the detection of bladder cancer. Markers have not been evaluated for screening in high-risk populations, and there is a gap in knowledge of the most accurate screening method. Early detection of bladder cancer has the potential to identify disease at an earlier stage resulting in a lower burden of treatment, improved quality of life, and improved survival. This study will prospectively screen patients at high risk for the development of bladder cancer at bi-annual intervals with a commonly available urinalysis test that assess for microhematuria and urine based molecular markers. This is a single arm study. The outcomes from the experimental arm will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Urothelial Carcinoma, Hematuria, Smoking Cessation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCa Early Screening Group
Arm Type
Experimental
Arm Description
All participants undergo Urinalysis testing every 6 months for 2 years. Based on the RBC count, each participant will go through each of the screening procedures : [cystoscopy + Upper tract imaging] or [urine marker cancer testing with Cxbladder triage + Upper tract imaging] or [Repeat urinalysis] Patients with suspicious findings on cystoscopy or imaging will get treatment as per standard of care. Their outcomes will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).
Arm Title
Historical Control Group
Arm Type
No Intervention
Arm Description
This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).
Intervention Type
Diagnostic Test
Intervention Name(s)
Urinalysis
Intervention Description
Urine analysis (every 6 months for 2 years); Patients with <3 red blood cells (RBCs) per high-powered field (HPF) will repeat screening at 6-month intervals for an average of 2 years. If RBCs are 3-25 RBSc/HPF- subjects will undergo- [cystoscopy + Upper tract imaging] or [urine marker cancer testing with Cxbladder triage + Upper tract imaging]. If >25 RBCs, subjects will get - [cystoscopy + Upper tract imaging].
Primary Outcome Measure Information:
Title
Incidence of Bladder cancer (BCa)
Description
Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Smoking cessation
Description
Smoking cessation is measured by number of participants who were referred to smoking cessation treatment
Time Frame
3 years
Title
Screening interval
Description
Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant
Time Frame
approx. every 6 months for up to 2 years
Title
Screening interval
Description
Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant
Time Frame
approx. every 12 months for up to 2 years
Title
Number of participants with positive/ negative markers and findings on cystoscopy
Description
Performance of urinalysis and molecular markers is assessed by the count of participants with positive/ negative markers and findings on cystoscopy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 50 Smoking: ≥15 pack-year smoking history Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners Exclusion Criteria: Prior history of bladder, kidney, or prostate cancer Prior evaluation of micro or gross hematuria within the last 2 years Do not provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Lotan, MD
Phone
214-648-0389
Email
yair.lotan@UTsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Lotan, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonobia Garrett
Phone
214-645-8787
First Name & Middle Initial & Last Name & Degree
Yair Lotan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Bladder Cancer Screening Trial

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