A Diagnostic for the Early Detection of Bladder Cancer

A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bladder Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90712
      • Long Beach VA Healthcare System
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Men and women 50 years and older who have greater than a 20 pack year history of tobacco use.

Description

Inclusion Criteria:

Participants must be:

1. Age 50 years or older
2. >20 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Cancer Institute (NCI); VA Long Beach Healthcare System; Nonagen Bioscience Corporation
• Investigators: Principal Investigator: Hideki Furuya, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: IIT2021-19-Furyua-EarlyDx; R01CA277810 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No