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A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03193515
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:
Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

Condition or disease
Bladder Cancer

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Multiplex ELISA Assay for Surveilling Patients With History of 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: 2 years ]
    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 prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.


Secondary Outcome Measures :
  1. Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck. [ Time Frame: 2 years ]

    To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.

    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.



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


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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
Patients with a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
Criteria

Inclusion Criteria

Participants must be:

  • Age 18 years or older
  • Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
  • Participants may be treated with adjuvant intravesical therapy
  • Willing and able to give written informed consent (see Appendix 1)
  • Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion Criteria:

Participants must not:

  • Have had radical cystectomy
  • History of previous cancer (excluding bladder, 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 surveillance regimen

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): NCT03193515


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: NCT03193515     History of Changes
Other Study ID Numbers: Rosser-2015-6
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
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases