ACTIVE_NOT_RECRUITING

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

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Conditions

Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-12-30
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03193528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Have documented or reported gross hematuria within 3 month of study enrollment
  3. * Willing and able to give written informed consent
  4. * Have history of BCa
  5. * History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years
  6. * Have a known active urinary tract infection or urinary retention
  7. * 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
  8. * Have ureteral stents, nephrostomy tubes or bowel interposition
  9. * Have recent genitourinary instrumentation (within 10 days prior to signing consent)
  10. * Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Charles Rosser, MD
STUDY_DIRECTOR
Nonagen Bioscience Corporation
Hideki Furuya, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
University of Rochester Medical Center
Rochester, New York, 14627
United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Charles Rosser, MD, STUDY_DIRECTOR, Nonagen Bioscience Corporation
  • Hideki Furuya, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-30
Study Completion Date2026-07

Study Record Updates

Study Start Date2016-12-30
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Bladder Cancer