NCT04564781

Brief Summary

To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
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 Progress60%
Sep 2020Feb 2030

Study Start

First participant enrolled

September 18, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

9.4 years

First QC Date

September 21, 2020

Last Update Submit

February 2, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.

    present through 04/30/2027

Secondary Outcomes (1)

  • Sensitivity and specificity of multiplex immunoassay will be compared to panel of urinary cytokines.

    present through 04/30/2027

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with recently diagnosed intermediate or high risk non-muscle invasive bladder cancer, who are destined to undergo intravesical BCG therapy.

You may qualify if:

  • Age 18 years or older
  • Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG
  • Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG
  • Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within 90 days prior to scheduled BCG
  • Patients must have intermediate or high-grade bladder cancer as defined by 2004 WHO/ISUP classification
  • Patients must not have pure squamous cell carcinoma or adenocarcinoma.
  • Patients' disease must not have micropapillary components.
  • Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to BCG: CT urogram, intravenous pyelogram, MR urogram, or retrograde pyelograms.
  • No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
  • Participants may be treated with immediate post-operative intravesical instillation of a chemotherapeutic agent
  • Scheduled to undergo intravesical BCG therapy within 4 weeks of signing consent.
  • Willing and able to give written informed consent (see Appendix 1)
  • Willing to provide voided urine sample

You may not qualify if:

  • Previous intravesical BCG therapy
  • Patients must not be taking oral glucocorticoids at the time of registration.
  • Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
  • Patients must not have known history of tuberculosis.
  • Have incomplete TUR, i.e., visible residual disease
  • Have had radical cystectomy
  • 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 2 years before consent, otherwise repeat.
  • Have ureteral stents, nephrostomy tubes or bowel interposition
  • Have recent genitourinary instrumentation (within 7 days prior to signing consent)
  • Be unable or unwilling to complete BCG induction and maintenance regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

UCSF

San Francisco, California, 94143, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Kyoto University

Kyoto, Kyoto, 606-8501, Japan

RECRUITING

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

Voided urine samples

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, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Rosser, MD

CONTACT

3104233713Charles.rosser@cshs.org

Amy Oppenheimer

CONTACT

3104233713Amy.Oppenheim@cshs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

September 18, 2020

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)JP(1)