A Diagnostic for the Early Detection of Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347342
• Other study ID #: IIT2021-19-Furyua-EarlyDx
• Secondary ID: R01CA277810
• Status: Recruiting
• Start date: April 29, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Charles J Rosser
• Phone: 310-423-0622
• Email: charles.rosser[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

Description:

Environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. To date, there are no diagnostics capable of detecting bladder cancer early, that is prior to clinical presentation. Because of this severe limitation, nearly 30% of patients initially present with stage 2 and higher bladder cancer. Stage 2 bladder cancer has a 5-year survival of 50%, while stage 3/4 have a 5-year survival of <20%. Ideally, bladder cancer would be preventable. Unfortunate, this has not come to fruition. If these stage 2-4 bladder cancer cases could be detected at Stage 1 (5-yr survival >94%), then its possible to see an improvement in bladder cancer survival rates (21-23). in this study, a urine-based diagnostic that possesses the potential to accurately identify patients who harbor bladder cancer prior to clinical manifestation will be tested.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2026
• Est. primary completion date: March 27, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Participants must be:

1. Age 50 years or older

2. >30 pack year history of tobacco exposure

3. Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.

4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic

5. Willing and able to give written informed consent

6. Willing to provide voided urine sample

7. Be able and willing to complete semi-annual research clinic visits for 4 years Exclusion Criteria:

Participants must not have:

1. History of hematuria (microscopic or gross) within 2 years of signing consent.

2. Previous history of bladder cancer

3. A known active urinary tract infection or urinary retention

4. An active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.

5. An ureteral stents, nephrostomy tubes or bowel interposition

6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Long Beach VA Healthcare System	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Cancer Institute (NCI), Nonagen Bioscience Corporation, VA Long Beach Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To assess the ability to recruit and retain an appropriate high-risk group of subjects into a 4-year longitudinal study monitoring them for the development of bladder cancer.	Ability to recruit	5 years
Primary	2. To report the sensitivity and specificity of the multiplex immunoassay ability to detect bladder cancer in patients with high risk of developing bladder cancer: >50 years and >40 pack year history of tobacco exposure.	Performance of multiplex test in this study	5 years
Primary	3. To develop a prediction risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.	Development of a risk calculator	5 years