Recruiting

Bladder Cancer

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03193541

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT03193541

Start date

Dec 30, 2016

Status verified date

Feb, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Charles Rosser, MD

310-423-5609charles.rosser@cshs.org

Locations

VA Long Beach Healthcare System

Recruiting

Long Beach, California, United States, 90822

Contacts

Mina Behdad

Mina.Behdad@va.gov

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Amy Oppenheim

310-423-3713Amy.Oppenheim@cshs.org

Principal Investigator:

Hideki Furuya, PhD

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ankush Sachdeva

asachdeva@mednet.ucla.edu

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Clemente Reyes

949-791-3049clemente.reyesrodriguez@hoag.org

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

Contacts

Natalie Carroll

Natalie_Carroll@URMC.Rochester.edu

UT Southwestern Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Maricruz Ibarra

Maricruz.Ibarra@UTSouthwestern.edu

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-02-04.