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A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03193528
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Texas
Information provided by (Responsible Party):
Charles Rosser, Cedars-Sinai Medical Center

Brief 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 gross hematuria.

Condition or disease
Bladder Cancer

Detailed Description:

Hematuria is the most common presentation of BCa with 22% of patients with gross 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 (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose 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 gross hematuria.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
Actual Study Start Date : December 30, 2016
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer




Primary Outcome Measures :
  1. To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort. [ Time Frame: 1 year ]
  2. To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Urine collection (minimal 50 mL) and cystoscopy (+ biopsy w/in 4 weeks, if abnormal noted)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Have documented or reported gross hematuria within 3 month of study enrollment
  • Willing and able to give written informed consent

Exclusion Criteria (patients must not):

  • Have history of BCa
  • History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years
  • 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) Serum creatinine value can be up to 60 days before consent, otherwise repeat
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193528


Contacts
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Contact: Charles Rosser, MD 310-423-5609 charles.rosser@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Amy Oppenheim    310-423-3713    Amy.Oppenheim@cshs.org   
United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Yair Lotan    214-648-0389    yair.lotan@utsouthwestern.edu   
Japan
Department of Urology, Nara Medical University Recruiting
Nara, Japan
Contact: Satoshi Anai    +81-744-22-3051    sanai@naramed-u.ac.jp   
Sponsors and Collaborators
Charles Rosser
Fred Hutchinson Cancer Research Center
University of Texas
Investigators
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Principal Investigator: Charles Rosser, MD Cedars-Sinai Medical Center
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Responsible Party: Charles Rosser, Sponsor-Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03193528    
Other Study ID Numbers: Rosser-2015-7
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Hematuria
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urination Disorders
Hemorrhage
Pathologic Processes