Bladder CancerNCT03193541
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
An observational study of Bladder Cancer, run by Cedars-Sinai Medical Center at 8 sites in 2 countries.
Trial summary
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- How many people
- 900 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 Dec 2016to Feb 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Adults, age 18 and older who have documented microscopic hematuria within the past 3 months who are referred for cystoscopy and are willing to participate
Who may be able to join
- Age 18 years or older
- Have documented or reported microscopic hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Who cannot join
- Have history of BCa
- History of previous cancer (excluding basal and squamous cell skin cancer)
- Have a known active urinary tract infection or urinary retention
- Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL)
- Have ureteral stents, nephrostomy tubes or bowel interposition
- Have recent genitourinary instrumentation (within 10 days prior to signing consent)
- Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Maricruz Ibarra, Maricruz.Ibarra@UTSouthwestern.edu
- Recruiting
VA Long Beach Healthcare System
Long Beach, California, 90822
Mina Behdad, Mina.Behdad@va.gov
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Amy Oppenheim, 310-423-3713, Amy.Oppenheim@cshs.org
Hideki Furuya, PhD
- Recruiting
UCLA Medical Center
Los Angeles, California, 90095
Ankush Sachdeva, asachdeva@mednet.ucla.edu
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Clemente Reyes, 949-791-3049, clemente.reyesrodriguez@hoag.org
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
Natalie Carroll, Natalie_Carroll@URMC.Rochester.edu
Japan2 sites, 2 recruiting
- Recruiting
Nara Prefecture Seiwa Medical Center
Nara, Nara, 636-0802
Satoshi Anai, MD
- Recruiting
Nara Medical University
Nara
Takuto Shimizu, MD
About this study
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
Read the detailed description
Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.
We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
- 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.
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
Measured: 1 year
Secondary outcomes (1)
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start30 Dec 2016
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nonagen Bioscience Corporation, Nara Medical University, University of California, Los Angeles, University of Rochester, National Cancer Institute (NCI), University of Texas, Southwestern Medical Center at Dallas, VA Long Beach Healthcare System, Nara Prefecture Seiwa Medical Center, University of Hawaii Cancer Research Center, Fred Hutchinson Cancer Center, Hoag Memorial Hospital Presbyterian
- Responsible party
- Principal investigator, Charles Rosser, Cedars-Sinai Medical Center
- Investigators
- Charles Rosser, MD, Study director, Nonagen Bioscience CorporationHideki Furuya, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193541
- Sponsor's protocol ID
- Rosser-2015-8
- Other IDs
- R01CA198887
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2017
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9;24(1):791. doi: 10.1186/s12967-026-08245-4.
PubMed 42106837Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
PubMed 38167321Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.
PubMed 38045238
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
- ClinicalTrials.gov ID
- NCT03193541
- Acronym / sponsor ID
- Rosser-2015-8
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Nonagen Bioscience Corporation, Nara Medical University, University of California, Los Angeles, University of Rochester, National Cancer Institute (NCI), University of Texas, Southwestern Medical Center at Dallas, VA Long Beach Healthcare System, Nara Prefecture Seiwa Medical Center, University of Hawaii Cancer Research Center, Fred Hutchinson Cancer Center, Hoag Memorial Hospital Presbyterian
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 20 Jun 2017 (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 BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
Detailed description
Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.
We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults, age 18 and older who have documented microscopic hematuria within the past 3 months who are referred for cystoscopy and are willing to participate
Key inclusion criteria (3 listed)
- Age 18 years or older
- Have documented or reported microscopic hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Key exclusion criteria (7 listed)
- Have history of BCa
- History of previous cancer (excluding basal and squamous cell skin cancer)
- Have a known active urinary tract infection or urinary retention
- Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL)
- Have 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
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
Time frame: 1 year
1 secondary outcome
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.
Time frame: 1 year
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 4 Feb 2026.
- Derived from this study: PubMed 42106837Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9;24(1):791. doi: 10.1186/s12967-026-08245-4.
- Derived from this study: PubMed 38167321Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
- Derived from this study: PubMed 38045238Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.
- Individual participant dataSharing planned: No
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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.
Charles Rosser, MD study director
Nonagen Bioscience Corporation
Hideki Furuya, PhD principal investigator
Cedars-Sinai Medical Center
8 sites in 2 countries: 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 8 sites in 2 countries.
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 3 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: looking for participants now, as of the sponsor's last update on 4 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 8 sites in United States, Japan. 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?
Contact Charles Rosser, MD (310-423-5609, charles.rosser@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193541, which also lists 3 linked publications.
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 4 Feb 2026.