NCT03193528

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 gross hematuria.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Dec 2016Jul 2026

Study Start

First participant enrolled

December 30, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

9.5 years

First QC Date

June 17, 2017

Last Update Submit

February 2, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 cohort of 450 participants presenting with gross hematuria.

    1 year

Secondary Outcomes (2)

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

    1 year

  • 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.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate

You may qualify if:

  • Age 18 years or older
  • Have documented or reported gross hematuria within 3 month of study enrollment
  • Willing and able to give written informed consent

You may not qualify if:

  • Have history of BCa
  • History of previous cancer (excluding 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 hematuria evaluation (i.e., cystoscopy and upper tract imaging)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of Rochester Medical Center

Rochester, New York, 14627, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Department of Urology, Nara Medical University

Nara, Japan

Location

Nara Precfecture Seiwa Medical Center

Nara, Japan

Location

Related Publications (2)

  • 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.

    PMID: 38167321DERIVED

  • 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.

    PMID: 38045238DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine collection (minimal 50 mL) and cystoscopy (+ biopsy w/in 4 weeks, if abnormal noted)

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Charles Rosser, MD

    Nonagen Bioscience Corporation

    STUDY DIRECTOR

  • Hideki Furuya, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2017

First Posted

June 20, 2017

Study Start

December 30, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)US(4)