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

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ClinicalTrials.gov Identifier: NCT03193541
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Texas
Information provided by (Responsible Party):
University of Hawaii

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 microscopic hematuria.

Condition or disease
Bladder Cancer

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.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic 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. Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek. [ 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
Sampling Method:   Non-Probability Sample
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
Criteria

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)

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): NCT03193541


Contacts
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Contact: Charles Rosser, MD 808-586-2979 cjrosser@hawaii.edu

Locations
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United States, Hawaii
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Charles Rosser, MD    808-586-2979      
Sponsors and Collaborators
University of Hawaii
Fred Hutchinson Cancer Research Center
University of Texas

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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03193541     History of Changes
Other Study ID Numbers: Rosser-2015-8
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
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