RECRUITING

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

Conditions

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

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.

Official Title

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

Quick Facts

Study Start:2016-12-30
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03193515

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. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Have had radical cystectomy
  2. * History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
  3. * Have a known active urinary tract infection or urinary retention
  4. * 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.
  5. * Have ureteral stents, nephrostomy tubes or bowel interposition
  6. * Have recent genitourinary instrumentation (within 10 days prior to signing consent)
  7. * Be unable or unwilling to complete the surveillance regimen

Contacts and Locations

Study Contact

Charles Rosser, MD
CONTACT
310-423-5609
Charles.Rosser@cshs.org

Principal Investigator

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

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California San Francisco
San Francisco, California, 94158
United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

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

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 Date2026-02

Study Record Updates

Study Start Date2016-12-30
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Bladder Cancer