- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03193541
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Charles Rosser, MD
- Phone Number: 310-423-5609
- Email: charles.rosser@cshs.org
Study Locations
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Nara, Japan
- Recruiting
- Nara Medical University
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Contact:
- Takuto Shimizu, MD
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Nara, Japan, 636-0802
- Recruiting
- Nara Prefecture Seiwa Medical Center
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Contact:
- Satoshi Anai, MD
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California
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Long Beach, California, United States, 90822
- Recruiting
- VA Long Beach Healthcare System
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Contact:
- Mina Behdad
- Email: Mina.Behdad@va.gov
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
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Contact:
- Amy Oppenheim
- Phone Number: 310-423-3713
- Email: Amy.Oppenheim@cshs.org
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Principal Investigator:
- Hideki Furuya, PhD
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA Medical Center
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Contact:
- Ankush Sachdeva
- Email: asachdeva@mednet.ucla.edu
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New York
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Rochester, New York, United States, 14620
- Recruiting
- University of Rochester Medical Center
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Contact:
- Natalie Carroll
- Email: Natalie_Carroll@URMC.Rochester.edu
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Texas
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Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center at Dallas
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Contact:
- Maricruz Ibarra
- Email: Maricruz.Ibarra@UTSouthwestern.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria (participants must not):
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Charles Rosser, MD, Nonagen Bioscience Corporation
- Principal Investigator: Hideki Furuya, PhD, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Hemorrhage
- Urination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Bladder Neoplasms
- Hematuria
Other Study ID Numbers
- Rosser-2015-8
- R01CA198887 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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