NCT05347342

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2022Jan 2029

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 29, 2022

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

April 20, 2022

Last Update Submit

January 31, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participants must be:
  • Age 50 years or older
  • \>20 pack year history of tobacco exposure
  • 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.
  • Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
  • Willing and able to give written informed consent
  • Willing to provide voided urine sample
  • Be able and willing to complete semi-annual research clinic visits for 4 years

You may not qualify if:

  • Participants must not have:
  • History of hematuria (microscopic or gross) within 2 years of signing consent.
  • Previous history of bladder cancer
  • A known active urinary tract infection or urinary retention
  • 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.
  • An ureteral stents, nephrostomy tubes or bowel interposition
  • A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long Beach VA Healthcare System

Long Beach, California, 90712, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine collection (minimal 50 mL) yearly for 4 years of screening.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Hideki Furuya

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

April 29, 2022

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

US(2)