Bladder CancerNCT05347342
A Diagnostic for the Early Detection of Bladder Cancer
An observational study of Bladder Cancer, run by Cedars-Sinai Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2022to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women 50 years and older who have greater than a 20 pack year history of tobacco use.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long Beach VA Healthcare System
Long Beach, California, 90712
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start29 Apr 2022
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nonagen Bioscience Corporation, National Cancer Institute (NCI), VA Long Beach Healthcare System
- Responsible party
- Principal investigator, Charles Rosser, Cedars-Sinai Medical Center
- Investigators
- Hideki Furuya, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347342
- Sponsor's protocol ID
- IIT2021-19-Furyua-EarlyDx
- Other IDs
- R01CA277810
- Status last verified
- Jan 2026
- First submitted
- 20 Apr 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer
- ClinicalTrials.gov ID
- NCT05347342
- Acronym / sponsor ID
- IIT2021-19-Furyua-EarlyDx
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Nonagen Bioscience Corporation, National Cancer Institute (NCI), VA Long Beach Healthcare System
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women 50 years and older who have greater than a 20 pack year history of tobacco use.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 5 years
Ability to recruit
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.
Time frame: 5 years
Performance of multiplex test in this study
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.
Time frame: 5 years
Development of a risk calculator
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hideki Furuya principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Cedars-Sinai Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.