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RecruitingObservational

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

NCT ID: NCT03193541Sponsor: Cedars-Sinai Medical CenterLast updated: 2026-02-04

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.

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.

Outcome measures

Primary

  • Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.

    Time frame: 1 year

Secondary

  • Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.

    Time frame: 1 year

Eligibility criteria

Sex: AllAge: 18 Years to 90 Years
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 locations (6)

VA Long Beach Healthcare System

Long Beach, California, 90822

Recruiting
Mina Behdad · Contact
Mina.Behdad@va.gov

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting
Amy Oppenheim · Contact
310-423-3713Amy.Oppenheim@cshs.org
Hideki Furuya, PhD · Principal Investigator

UCLA Medical Center

Los Angeles, California, 90095

Recruiting
Ankush Sachdeva · Contact
asachdeva@mednet.ucla.edu

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Recruiting
Clemente Reyes · Contact
949-791-3049clemente.reyesrodriguez@hoag.org

University of Rochester Medical Center

Rochester, New York, 14620

Recruiting
Natalie Carroll · Contact
Natalie_Carroll@URMC.Rochester.edu

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390

Recruiting
Maricruz Ibarra · Contact
Maricruz.Ibarra@UTSouthwestern.edu

References

  • Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9. doi: 10.1186/s12967-026-08245-4. Online ahead of print.(PubMed)
  • Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.(PubMed)
  • Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.(PubMed)